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Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine

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ClinicalTrials.gov Identifier: NCT03078556
Recruitment Status : Completed
First Posted : March 13, 2017
Results First Posted : February 21, 2019
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Infection, Human Immunodeficiency Virus
Interventions Drug: Dolutegravir
Drug: Lamivudine
Drug: Dolutegravir + Lamivudine FDC Formulation 1
Drug: Dolutegravir + Lamivudine FDC Formulation 2
Enrollment 154
Recruitment Details The study was conducted in 2 parts (Part 1 and Part 2) at a single center in the United States from 27-March-2017 to 18-August-2017 and 154 participants (78 in Part 1 and 76 in Part 2) were randomized. First 16 participants completing the first 2 dosing periods, returned for a 3rd treatment period and received single dose of FDC with high fat meal
Pre-assignment Details A total of 283 (Part 1: 150, Part 2: 133) participants were screened for this study; 125 (Part 1: 72, Part2: 53) participants were screen failures (SF) and 4 participants were reserved but not used. The reasons for SF: inclusion/exclusion criteria not met (105), withdrew consent (18), physician decision (2).
Arm/Group Title Part 1:DTG+EPIVIR/DTG+3TC Monolayer/DTG+3TC Monolayer-fed Part 1:DTG+3TC Monolayer/DTG+EPIVIR/DTG+3TC Monolayer-fed Part 2:DTG+EPIVIR/DTG+3TC Bilayer/DTG+3TC Bilayer-fed Part 2:DTG+3TC Bilayer/DTG+EPIVIR /DTG+3TC Bilayer-fed
Hide Arm/Group Description Participants were randomized to receive dolutegravir (DTG) 50 milligram (mg) tablet plus a single lamivudine (3TC) tablet in Period 1 followed by DTG 50 mg/3TC 300 mg fixed dose combination (FDC) monolayer formulation in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods. Participants were randomized to receive DTG 50 mg/3TC 300 mg FDC monolayer formulation in Period 1 followed by DTG 50 mg tablet plus a single 3TC tablet in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods. Participants were randomized to receive DTG 50 mg tablet plus a single 3TC tablet in Period 1 followed by DTG 50 mg/3TC 300 mg FDC bilayer formulation in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods. Participants were randomized to receive DTG 50 mg/3TC 300 mg FDC bilayer formulation in Period 1 followed by DTG 50 mg tablet plus a single 3TC tablet in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods.
Period Title: Treatment Period 1 (4 Days)
Started 39 39 38 38
Completed 39 38 38 38
Not Completed 0 1 0 0
Reason Not Completed
Adverse Event             0             1             0             0
Period Title: Washout Period 1 (7 Days)
Started 39 38 38 38
Completed 37 36 37 37
Not Completed 2 2 1 1
Reason Not Completed
Lost to Follow-up             2             0             1             0
Adverse Event             0             1             0             1
Physician Decision             0             1             0             0
Period Title: Treatment Period 2 (4 Days)
Started 37 36 37 37
Completed 37 36 37 37
Not Completed 0 0 0 0
Period Title: Washout Period 2 (7 Days)
Started 9 7 7 9
Completed 9 7 7 9
Not Completed 0 0 0 0
Period Title: Treatment Period 3 (4 Days)
Started 9 7 7 9
Completed 9 7 7 9
Not Completed 0 0 0 0
Arm/Group Title Part 1 Part 2 Total
Hide Arm/Group Description Participants were randomized into treatment sequence A/B (treatment A in Period 1 followed by B in Period 2) or B/A (treatment B in Period 1 followed by A in Period 2), where A=dolutegravir (DTG) 50 milligram (mg) tablet plus a single lamivudine (3TC) tablet and treatment B= DTG 50 mg/3TC 300 mg fixed dose combination (FDC) monolayer formulation. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout period of at least 7 days between each treatment period. In treatment periods 1 and 2, single dose of the treatments were administered in the fasted state. Participants were randomized into treatment sequence A/C (treatment A in Period 1 followed by C in Period 2) or C/A (treatment C in Period 1 followed by A in Period 2), where A=DTG 50 mg tablet plus a single 3TC tablet and treatment C= DTG 50 mg/3TC 300 mg FDC bilayer formulation. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout period of at least 7 days between each treatment period. Total of all reporting groups
Overall Number of Baseline Participants 78 76 154
Hide Baseline Analysis Population Description
Safety Population: All participants who enrolled in the study and received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 76 participants 154 participants
29.4  (9.37) 31.6  (11.18) 30.5  (10.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 76 participants 154 participants
Female
25
  32.1%
26
  34.2%
51
  33.1%
Male
53
  67.9%
50
  65.8%
103
  66.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 76 participants 154 participants
American Indian or Alaska Native
6
   7.7%
1
   1.3%
7
   4.5%
Asian- Central/South Asian Heritage
1
   1.3%
1
   1.3%
2
   1.3%
Asian- East Asian Heritage
0
   0.0%
1
   1.3%
1
   0.6%
Asian- South East Asian Heritage
1
   1.3%
0
   0.0%
1
   0.6%
Black or African American
20
  25.6%
23
  30.3%
43
  27.9%
White-White/Caucasian/European Heritage
50
  64.1%
50
  65.8%
100
  64.9%
1.Primary Outcome
Title Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity [AUC (0-Inf)] of Plasma DTG and 3TC in the Fasted State: Part 1
Hide Description Blood samples were collected at indicated time points to study the pharmacokinetic (PK) profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter Bioequivalence (BE) Summary Population comprised of all participants who have evaluable PK parameters for both analytes and for both Period 1 and Period 2.
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 73 73
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*micrograms per milliliter
DTG
43.1456
(39.29%)
54.8793
(31.60%)
3TC
12.3337
(19.88%)
12.7603
(19.77%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.2710
Confidence Interval (2-Sided) 90%
1.1894 to 1.3582
Estimation Comments Ratio (B/A) of plasma DTG has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.0341
Confidence Interval (2-Sided) 90%
1.0097 to 1.0591
Estimation Comments Ratio (B/A) of plasma 3TC has been presented.
2.Primary Outcome
Title AUC (0-Inf) of Plasma DTG and 3TC in the Fasted State: Part 2
Hide Description Blood samples were collected at given time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted conditions in Periods 1 and 2 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed, represented by n= X,X in the category titles.
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 74 74
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*micrograms per milliliter
DTG, n= 74,74 Number Analyzed 74 participants 74 participants
47.2391
(40.29%)
54.5594
(32.12%)
3TC, n= 73,74 Number Analyzed 73 participants 74 participants
12.7713
(18.63%)
13.5624
(17.94%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.1550
Confidence Interval (2-Sided) 90%
1.0699 to 1.2468
Estimation Comments Ratio (C/A) of plasma DTG has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.0635
Confidence Interval (2-Sided) 90%
1.0413 to 1.0861
Estimation Comments Ratio (C/A) of plasma 3TC has been presented.
3.Primary Outcome
Title Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC[0-t]) of Plasma DTG and 3TC in the Fasted State: Part 1
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population.
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 73 73
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*micrograms per milliliter
DTG
41.4207
(39.36%)
52.8754
(31.16%)
3TC
12.1571
(20.19%)
12.6147
(19.75%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.2756
Confidence Interval (2-Sided) 90%
1.1919 to 1.3651
Estimation Comments Ratio (B/A) of plasma DTG has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.0372
Confidence Interval (2-Sided) 90%
1.0116 to 1.0634
Estimation Comments Ratio (B/A) of plasma 3TC has been presented.
4.Primary Outcome
Title AUC(0-t) of Plasma DTG and 3TC in the Fasted State: Part 2
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 74 74
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*microgram/milliliter
DTG
45.2043
(39.57%)
52.3372
(31.46%)
3TC
12.4790
(19.19%)
13.3552
(18.10%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.1578
Confidence Interval (2-Sided) 90%
1.0718 to 1.2507
Estimation Comments Ratio (C/A) of plasma DTG has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.0702
Confidence Interval (2-Sided) 90%
1.0464 to 1.0946
Estimation Comments Ratio (C/A) of plasma 3TC has been presented.
5.Primary Outcome
Title Maximum Observed Concentration (Cmax) of Plasma DTG and 3TC in the Fasted State: Part 1
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 73 73
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
DTG
2.4065
(38.95%)
3.0817
(31.86%)
3TC
2.6650
(29.04%)
3.1885
(28.07%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.2805
Confidence Interval (2-Sided) 90%
1.1890 to 1.3790
Estimation Comments Ratio (B/A) of plasma DTG has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.1956
Confidence Interval (2-Sided) 90%
1.1437 to 1.2498
Estimation Comments Ratio (B/A) of plasma 3TC has been presented.
6.Primary Outcome
Title Cmax of Plasma DTG and 3TC in the Fasted State: Part 2
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg B: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50mg and 3TC 300mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 74 74
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
DTG
2.5531
(36.38%)
2.9132
(30.55%)
3TC
2.4428
(28.25%)
3.2185
(29.30%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.1410
Confidence Interval (2-Sided) 90%
1.0533 to 1.2361
Estimation Comments Ratio (C/A) of plasma DTG has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.3176
Confidence Interval (2-Sided) 90%
1.2616 to 1.3760
Estimation Comments Ratio (C/A) of plasma 3TC has been presented.
7.Secondary Outcome
Title Absorption Lag Time (Tlag) of DTG and 3TC in Fasted State: Part 1
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 73 73
Median (Full Range)
Unit of Measure: Hour
DTG
0.0000
(0.0000 to 0.756)
0.0000
(0.0000 to 0.261)
3TC
0.0000
(0.0000 to 0.252)
0.0000
(0.0000 to 0.261)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.000
Confidence Interval (2-Sided) 90%
0.000 to 0.000
Estimation Comments Median Difference of plasma DTG has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.000
Confidence Interval (2-Sided) 90%
0.000 to 0.000
Estimation Comments Median Difference of plasma 3TC has been presented.
8.Secondary Outcome
Title Tlag of DTG and 3TC in Fasted State: Part 2
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 74 74
Median (Full Range)
Unit of Measure: Hour
DTG
0.0000
(0.0000 to 0.261)
0.0000
(0.0000 to 0.266)
3TC
0.0000
(0.0000 to 0.0000)
0.0000
(0.0000 to 0.252)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.000
Confidence Interval (2-Sided) 90%
-0.004 to 0.000
Estimation Comments Median Difference of plasma DTG has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.000
Confidence Interval (2-Sided) 90%
0.000 to 0.000
Estimation Comments Median Difference of plasma 3TC has been presented.
9.Secondary Outcome
Title Time to Reach Maximum Plasma Concentration (Tmax) of DTG and 3TC in the Fasted State: Part 1
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population.
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 73 73
Median (Full Range)
Unit of Measure: Hour
DTG
2.0072
(0.500 to 8.009)
2.0017
(0.500 to 5.012)
3TC
1.0047
(0.500 to 4.005)
1.0008
(0.500 to 3.500)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.127
Confidence Interval (2-Sided) 90%
-0.500 to 0.248
Estimation Comments Median Difference of plasma DTG has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.126
Confidence Interval (2-Sided) 90%
-0.253 to -0.001
Estimation Comments Median Difference of plasma 3TC has been presented.
10.Secondary Outcome
Title Tmax of DTG and 3TC in the Fasted State: Part 2
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 74 74
Median (Full Range)
Unit of Measure: Hour
DTG
2.5008
(0.500 to 5.011)
2.5004
(0.500 to 6.001)
3TC
1.0063
(0.500 to 4.002)
1.0011
(0.500 to 3.501)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.127
Confidence Interval (2-Sided) 90%
-0.497 to 0.132
Estimation Comments Median Difference of plasma DTG has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.248
Confidence Interval (2-Sided) 90%
-0.376 to -0.001
Estimation Comments Median Difference of plasma 3TC has been presented.
11.Secondary Outcome
Title Time of the Last Quantifiable Concentration (Tlast) of DTG and 3TC in the Fasted State: Part 1
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 73 73
Median (Full Range)
Unit of Measure: Hour
DTG
72.0031
(48.000 to 74.636)
71.9303
(48.003 to 76.236)
3TC
71.9289
(47.673 to 74.636)
71.9303
(70.790 to 76.236)
12.Secondary Outcome
Title Tlast of DTG and 3TC in the Fasted State: Part 2
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 74 74
Median (Full Range)
Unit of Measure: Hour
DTG
71.6813
(48.006 to 75.301)
71.8243
(71.005 to 72.632)
3TC
71.7138
(48.000 to 75.301)
71.8153
(48.007 to 72.632)
13.Secondary Outcome
Title Time to Reach Half the Maximum Plasma Concentration (t1/2) of DTG and 3TC in the Fasted State: Part 1
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 73 73
Median (Full Range)
Unit of Measure: Hour
DTG
14.6917
(10.575 to 21.375)
14.7557
(10.461 to 21.392)
3TC
17.0395
(8.281 to 34.542)
17.3436
(12.436 to 34.675)
14.Secondary Outcome
Title t1/2 of DTG and 3TC in the Fasted State: Part 2
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed indicated by n=X in category titles.
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 74 74
Median (Full Range)
Unit of Measure: Hour
DTG, n= 74,74 Number Analyzed 74 participants 74 participants
15.1538
(9.711 to 21.966)
14.7893
(9.815 to 21.486)
3TC, n= 73,74 Number Analyzed 73 participants 74 participants
17.8421
(10.195 to 47.171)
18.1071
(7.367 to 48.613)
15.Secondary Outcome
Title Apparent Elimination Rate Constant (Lambda z) of DTG and 3TC in the Fasted State: Part 1
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 73 73
Median (Full Range)
Unit of Measure: Per hour
DTG
0.0472
(0.032 to 0.066)
0.0470
(0.032 to 0.066)
3TC
0.0407
(0.020 to 0.084)
0.0400
(0.020 to 0.056)
16.Secondary Outcome
Title Lambda z of DTG and 3TC in in the Fasted State: Part 2
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed (represented by n= X,X in the category titles).
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 74 74
Median (Full Range)
Unit of Measure: Per hour
DTG, n=74,74 Number Analyzed 74 participants 74 participants
0.0457
(0.032 to 0.071)
0.0469
(0.032 to 0.071)
3TC, n= 73,74 Number Analyzed 73 participants 74 participants
0.0388
(0.015 to 0.068)
0.0383
(0.014 to 0.094)
17.Secondary Outcome
Title Percentage of Extrapolated AUC (0 to Inf) of DTG and 3TC in the Fasted State: Part 1
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population.
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 73 73
Median (Full Range)
Unit of Measure: Percentage of AUC
DTG
3.4967
(1.015 to 15.084)
3.2582
(0.908 to 9.967)
3TC
1.0287
(0.343 to 7.305)
0.9052
(0.428 to 5.334)
18.Secondary Outcome
Title Percentage of Extrapolated AUC(0 to Inf) of DTG and 3TC in the Fasted State: Part 2
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed indicated by n=X in category titles.
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 74 74
Median (Full Range)
Unit of Measure: Percentage of AUC
DTG, n= 74,74 Number Analyzed 74 participants 74 participants
3.8923
(0.932 to 10.512)
3.5773
(0.659 to 9.570)
3TC, n= 73,74 Number Analyzed 73 participants 74 participants
1.2518
(0.344 to 6.409)
1.1432
(0.394 to 7.867)
19.Secondary Outcome
Title AUC of 0 to 24 Hours (AUC[0-24]) of DTG and 3TC in the Fasted State: Part 1
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 73 73
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
DTG
29.4257
(38.40%)
37.6112
(30.28%)
3TC
11.3960
(20.92%)
11.9418
(20.09%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.2774
Confidence Interval (2-Sided) 90%
1.1931 to 1.3676
Estimation Comments Ratio (B/A) of plasma DTG has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.0475
Confidence Interval (2-Sided) 90%
1.0185 to 1.0773
Estimation Comments Ratio (B/A) of plasma 3TC has been presented.
20.Secondary Outcome
Title AUC(0-24) of DTG and 3TC in the Fasted State: Part 2
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 74 74
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
DTG
31.5664
(37.73%)
36.6126
(30.93%)
3TC
11.6419
(20.23%)
12.5810
(18.50%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.1599
Confidence Interval (2-Sided) 90%
1.0711 to 1.2560
Estimation Comments Ratio (C/A) of plasma DTG has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.0807
Confidence Interval (2-Sided) 90%
1.0539 to 1.1081
Estimation Comments Ratio (C/A) of plasma 3TC has been presented.
21.Secondary Outcome
Title Apparent Oral Clearance (CL/F) of DTG and 3TC in the Fasted State: Part 1
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 73 73
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters per hour
DTG
1.1589
(39.29%)
0.9111
(31.60%)
3TC
24.3236
(19.88%)
23.5104
(19.77%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.7868
Confidence Interval (2-Sided) 90%
0.7363 to 0.8408
Estimation Comments Ratio (B/A) of plasma DTG has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.9670
Confidence Interval (2-Sided) 90%
0.9442 to 0.9904
Estimation Comments Ratio (B/A) of plasma 3TC has been presented.
22.Secondary Outcome
Title CL/F of DTG and 3TC in the Fasted State: Part 2
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles.
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 74 74
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters per hour
DTG, n= 74, 74 Number Analyzed 74 participants 74 participants
1.0584
(40.29%)
0.9164
(32.12%)
3TC, n= 73, 74 Number Analyzed 73 participants 74 participants
23.4901
(18.63%)
22.1200
(17.94%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.8658
Confidence Interval (2-Sided) 90%
0.8021 to 0.9347
Estimation Comments Ratio (C/A) of plasma DTG has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.9403
Confidence Interval (2-Sided) 90%
0.9207 to 0.9604
Estimation Comments Ratio (C/A) of plasma 3TC has been presented.
23.Secondary Outcome
Title Apparent Oral Volume of Distribution (Vz/F) of DTG and 3TC in the Fasted State: Part 1
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 73 73
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters
DTG
24.6254
(37.80%)
19.3399
(30.05%)
3TC
616.7365
(34.52%)
598.8651
(29.07%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.7859
Confidence Interval (2-Sided) 90%
0.7318 to 0.8440
Estimation Comments Ratio (B/A) of plasma DTG has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.9704
Confidence Interval (2-Sided) 90%
0.9157 to 1.0284
Estimation Comments Ratio (B/A) of plasma 3TC has been presented.
24.Secondary Outcome
Title Vz/F of DTG and 3TC in the Fasted State: Part 2
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed, represented by n= X,X in the category titles.
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 74 74
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters
DTG, n= 74, 74 Number Analyzed 74 participants 74 participants
23.1159
(37.18%)
19.8124
(32.73%)
3TC, n= 73, 74 Number Analyzed 73 participants 74 participants
650.7952
(35.55%)
599.5525
(34.28%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.8571
Confidence Interval (2-Sided) 90%
0.7914 to 0.9282
Estimation Comments Ratio (C/A) of plasma DTG has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.9153
Confidence Interval (2-Sided) 90%
0.8613 to 0.9728
Estimation Comments Ratio (C/A) of plasma 3TC has been presented.
25.Secondary Outcome
Title Concentration at 24 Hours Post-dose (C24) of DTG and 3TC in the Fasted State: Part 1
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population.
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 73 73
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
DTG
0.6373
(40.18%)
0.8059
(32.77%)
3TC
0.0331
(32.13%)
0.0318
(31.81%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.2632
Confidence Interval (2-Sided) 90%
1.1811 to 1.3511
Estimation Comments Ratio (B/A) of plasma DTG has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.9598
Confidence Interval (2-Sided) 90%
0.9268 to 0.9941
Estimation Comments Ratio (B/A) of plasma 3TC has been presented.
26.Secondary Outcome
Title C24 of DTG and 3TC in the Fasted State: Part 2
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 74 74
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
DTG
0.7065
(41.48%)
0.8071
(33.83%)
3TC
0.0366
(30.39%)
0.0350
(31.19%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.1425
Confidence Interval (2-Sided) 90%
1.0597 to 1.2317
Estimation Comments Ratio (C/A) of plasma DTG has been presented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.9548
Confidence Interval (2-Sided) 90%
0.9299 to 0.9804
Estimation Comments Ratio (C/A) of plasma 3TC has been presented.
27.Secondary Outcome
Title Last Quantifiable Concentration (Clast) of DTG and 3TC in the Fasted State: Part 1
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 73 73
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
DTG
0.0702
(58.85%)
0.0832
(56.42%)
3TC
0.0056
(43.03%)
0.0050
(37.58%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.1839
Confidence Interval (2-Sided) 90%
1.0921 to 1.2834
Estimation Comments Ratio (B/A) of plasma DTG has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.8874
Confidence Interval (2-Sided) 90%
0.8340 to 0.9443
Estimation Comments Ratio (B/A) of plasma 3TC has been presented
28.Secondary Outcome
Title Clast of DTG and 3TC in the Fasted State: Part 2
Hide Description Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter BE Summary Population
Arm/Group Title A: DTG 50 mg + EPIVIR 300 mg C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Overall Number of Participants Analyzed 74 74
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
DTG
0.0800
(66.94%)
0.0862
(65.26%)
3TC
0.0069
(47.83%)
0.0062
(41.60%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.0780
Confidence Interval (2-Sided) 90%
0.9958 to 1.1670
Estimation Comments Ratio (B/A) of plasma DTG has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection A: DTG 50 mg + EPIVIR 300 mg, C: DTG 50 mg/ 3TC 300 mg Bilayer FDC
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.9049
Confidence Interval (2-Sided) 90%
0.8474 to 0.9663
Estimation Comments Ratio (B/A) of plasma 3TC has been presented
29.Secondary Outcome
Title AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 1
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter food effect (FD) Summary Population comprised of participants who participated in the food effect part of the study and had evaluable PK parameters for both fed and fasted administration of the FDC tablet formulation.
Arm/Group Title B: DTG 50 mg/ 3TC 300 mg Monolayer FDC Bfed: DTG 50 mg/3TC 300 mg Monolayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Overall Number of Participants Analyzed 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
DTG
62.3435
(32.34%)
71.9777
(19.99%)
3TC
13.4357
(21.02%)
12.8668
(18.50%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B: DTG 50 mg/ 3TC 300 mg Monolayer FDC, Bfed: DTG 50 mg/3TC 300 mg Monolayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.1545
Confidence Interval (2-Sided) 90%
1.0208 to 1.3058
Estimation Comments Ratio (Bfed/B) of plasma DTG has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection B: DTG 50 mg/ 3TC 300 mg Monolayer FDC, Bfed: DTG 50 mg/3TC 300 mg Monolayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.9577
Confidence Interval (2-Sided) 90%
0.9126 to 1.0049
Estimation Comments Ratio (Bfed/B) of plasma 3TC has been presented
30.Secondary Outcome
Title AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 2
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title C: DTG 50 mg and 3TC 300 mg Bilayer FDC Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Overall Number of Participants Analyzed 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
DTG
57.6561
(35.93%)
76.4283
(22.36%)
3TC
14.6420
(18.50%)
13.3443
(20.34%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C: DTG 50 mg and 3TC 300 mg Bilayer FDC, Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.3256
Confidence Interval (2-Sided) 90%
1.1837 to 1.4845
Estimation Comments Ratio (Cfed/C) of plasma DTG has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection C: DTG 50 mg and 3TC 300 mg Bilayer FDC, Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.9114
Confidence Interval (2-Sided) 90%
0.8658 to 0.9593
Estimation Comments Ratio (Cfed/C) of plasma 3TC has been presented
31.Secondary Outcome
Title AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 1
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title B: DTG 50 mg/ 3TC 300 mg Monolayer FDC Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Overall Number of Participants Analyzed 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*microgram per milliliter
DTG
60.3212
(31.78%)
69.2560
(18.92%)
3TC
13.2818
(20.90%)
12.6491
(18.63%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B: DTG 50 mg/ 3TC 300 mg Monolayer FDC, Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.1481
Confidence Interval (2-Sided) 90%
1.0154 to 1.2982
Estimation Comments Ratio (Bfed/B) of plasma DTG has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection B: DTG 50 mg/ 3TC 300 mg Monolayer FDC, Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.9524
Confidence Interval (2-Sided) 90%
0.9086 to 0.9983
Estimation Comments Ratio (Bfed/B) of plasma 3TC has been presented
32.Secondary Outcome
Title AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 2
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title C: DTG 50 mg and 3TC 300 mg Bilayer FDC Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Overall Number of Participants Analyzed 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*microgram per milliliter
DTG
55.2176
(35.33%)
72.7545
(20.22%)
3TC
14.4706
(18.72%)
13.0923
(20.57%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C: DTG 50 mg and 3TC 300 mg Bilayer FDC, Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.3176
Confidence Interval (2-Sided) 90%
1.1750 to 1.4775
Estimation Comments Ratio (Cfed/C) of plasma DTG has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection C: DTG 50 mg and 3TC 300 mg Bilayer FDC, Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.9048
Confidence Interval (2-Sided) 90%
0.8592 to 0.9528
Estimation Comments Ratio (Cfed/C) of plasma 3TC has been presented
33.Secondary Outcome
Title Cmax of Plasma DTG and 3TC in the Fed State: Part 1
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title B: DTG 50 mg/ 3TC 300 mg Monolayer FDC Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Overall Number of Participants Analyzed 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
DTG
3.5068
(30.27%)
3.7900
(20.97%)
3TC
3.5413
(27.14%)
2.5132
(18.74%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B: DTG 50 mg/ 3TC 300 mg Monolayer FDC, Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.0808
Confidence Interval (2-Sided) 90%
0.9527 to 1.2261
Estimation Comments Ratio (Bfed/B) of plasma DTG has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection B: DTG 50 mg/ 3TC 300 mg Monolayer FDC, Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.7097
Confidence Interval (2-Sided) 90%
0.6474 to 0.7779
Estimation Comments Ratio (Bfed/B) of plasma 3TC has been presented
34.Secondary Outcome
Title Cmax of Plasma DTG and 3TC in the Fed State: Part 2
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title C: DTG 50 mg and 3TC 300 mg Bilayer FDC Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Overall Number of Participants Analyzed 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
DTG
3.1015
(35.62%)
3.7516
(21.31%)
3TC
3.5824
(35.18%)
2.4453
(33.88%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C: DTG 50 mg and 3TC 300 mg Bilayer FDC, Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.2096
Confidence Interval (2-Sided) 90%
1.0521 to 1.3908
Estimation Comments Ratio (Cfed/C) of plasma DTG has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection C: DTG 50 mg and 3TC 300 mg Bilayer FDC, Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.6826
Confidence Interval (2-Sided) 90%
0.5861 to 0.7950
Estimation Comments Ratio (Cfed/C) of plasma 3TC has been presented
35.Secondary Outcome
Title Tlag of DTG and 3TC in Fed State: Part 1
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title B: DTG 50 mg/ 3TC 300 mg Monolayer FDC Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Overall Number of Participants Analyzed 16 16
Median (Full Range)
Unit of Measure: Hour
DTG
0.0000
(0.0000 to 0.251)
0.2522
(0.0000 to 1.000)
3TC
0.0000
(0.0000 to 0.251)
0.0000
(0.0000 to 0.255)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B: DTG 50 mg/ 3TC 300 mg Monolayer FDC, Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.254
Confidence Interval (2-Sided) 90%
0.250 to 0.378
Estimation Comments Median Difference of plasma DTG has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection B: DTG 50 mg/ 3TC 300 mg Monolayer FDC, Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.125
Confidence Interval (2-Sided) 90%
0.000 to 0.127
Estimation Comments Median Difference of plasma 3TC has been presented
36.Secondary Outcome
Title Tlag of DTG and 3TC in Fed State: Part 2
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title C: DTG 50 mg and 3TC 300 mg Bilayer FDC Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Overall Number of Participants Analyzed 16 16
Median (Full Range)
Unit of Measure: Hour
DTG
0.0000
(0.0000 to 0.258)
0.1253
(0.0000 to 0.751)
3TC
0.0000
(0.0000 to 0.252)
0.0000
(0.0000 to 0.257)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C: DTG 50 mg and 3TC 300 mg Bilayer FDC, Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.126
Confidence Interval (2-Sided) 90%
0.000 to 0.250
Estimation Comments Median Difference of plasma DTG has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection C: DTG 50 mg and 3TC 300 mg Bilayer FDC, Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.000
Confidence Interval (2-Sided) 90%
0.000 to 0.125
Estimation Comments Median Difference of plasma 3TC has been presented
37.Secondary Outcome
Title Tmax of DTG and 3TC in the Fed State: Part 1
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title B: DTG 50 mg/ 3TC 300 mg Monolayer FDC Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Overall Number of Participants Analyzed 16 16
Median (Full Range)
Unit of Measure: Hour
DTG
1.5013
(0.503 to 5.002)
5.0006
(2.001 to 12.009)
3TC
1.0001
(0.500 to 2.001)
3.5003
(1.011 to 5.006)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B: DTG 50 mg/ 3TC 300 mg Monolayer FDC, Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 3.017
Confidence Interval (2-Sided) 90%
1.872 to 4.496
Estimation Comments Median Difference of plasma DTG has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection B: DTG 50 mg/ 3TC 300 mg Monolayer FDC, Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 2.113
Confidence Interval (2-Sided) 90%
1.500 to 2.751
Estimation Comments Median Difference of plasma 3TC has been presented
38.Secondary Outcome
Title Tmax of DTG and 3TC in the Fed State: Part 2
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title C: DTG 50 mg and 3TC 300 mg Bilayer FDC Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Overall Number of Participants Analyzed 16 16
Median (Full Range)
Unit of Measure: Hour
DTG
1.5007
(0.751 to 3.001)
5.0019
(1.011 to 8.004)
3TC
1.0003
(0.503 to 2.506)
2.7508
(1.001 to 6.001)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C: DTG 50 mg and 3TC 300 mg Bilayer FDC, Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 2.500
Confidence Interval (2-Sided) 90%
1.748 to 3.751
Estimation Comments Median Difference of plasma DTG has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection C: DTG 50 mg and 3TC 300 mg Bilayer FDC, Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 1.503
Confidence Interval (2-Sided) 90%
0.998 to 2.252
Estimation Comments Median Difference of plasma 3TC has been presented
39.Secondary Outcome
Title T1/2 of DTG and 3TC in the Fed State: Part 1
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title B: DTG 50 mg/ 3TC 300 mg Monolayer FDC Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Overall Number of Participants Analyzed 16 16
Median (Full Range)
Unit of Measure: Hour
DTG
14.5843
(12.077 to 16.806)
14.5816
(10.889 to 17.259)
3TC
18.3614
(12.509 to 30.759)
19.8579
(9.977 to 34.144)
40.Secondary Outcome
Title T1/2 of DTG and 3TC in the Fed State: Part 2
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title C: DTG 50 mg and 3TC 300 mg Bilayer FDC Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Overall Number of Participants Analyzed 16 16
Median (Full Range)
Unit of Measure: Hour
DTG
14.9828
(11.355 to 20.563)
15.1718
(12.193 to 19.945)
3TC
17.2250
(13.259 to 37.099)
19.7311
(13.384 to 27.781)
41.Secondary Outcome
Title Lambda z of DTG and 3TC in in the Fed State: Part 1
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title B: DTG 50 mg/ 3TC 300 mg Monolayer FDC Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Overall Number of Participants Analyzed 16 16
Median (Full Range)
Unit of Measure: Per hour
DTG
0.0475
(0.041 to 0.057)
0.0475
(0.040 to 0.064)
3TC
0.0378
(0.023 to 0.055)
0.0349
(0.020 to 0.069)
42.Secondary Outcome
Title Lambda z of DTG and 3TC in in the Fed State: Part 2
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title C: DTG 50 mg and 3TC 300 mg Bilayer FDC Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Overall Number of Participants Analyzed 16 16
Median (Full Range)
Unit of Measure: Per hour
DTG
0.0463
(0.034 to 0.061)
0.0457
(0.035 to 0.057)
3TC
0.0403
(0.019 to 0.052)
0.0351
(0.025 to 0.052)
43.Secondary Outcome
Title Clast of DTG and 3TC in in the Fed State: Part 1
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title B: DTG 50 mg/ 3TC 300 mg Monolayer FDC Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Overall Number of Participants Analyzed 16 16
Median (Full Range)
Unit of Measure: Micrograms per milliliter
DTG
0.1060
(0.035 to 0.180)
0.1190
(0.043 to 0.243)
3TC
0.0048
(0.003 to 0.014)
0.0066
(0.004 to 0.016)
44.Secondary Outcome
Title Clast of DTG and 3TC in in the Fed State: Part 2
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title C: DTG 50 mg and 3TC 300 mg Bilayer FDC Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Overall Number of Participants Analyzed 16 16
Median (Full Range)
Unit of Measure: Micrograms per milliliter
DTG
0.0975
(0.031 to 0.240)
0.1310
(0.051 to 0.363)
3TC
0.0059
(0.003 to 0.011)
0.0091
(0.003 to 0.015)
45.Secondary Outcome
Title Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 1
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title B: DTG 50 mg/ 3TC 300 mg Monolayer FDC Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Overall Number of Participants Analyzed 16 16
Median (Full Range)
Unit of Measure: Percentage of AUC
DTG
3.3305
(1.490 to 4.845)
3.8870
(1.094 to 6.134)
3TC
0.8856
(0.561 to 3.510)
1.4830
(0.788 to 4.324)
46.Secondary Outcome
Title Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 2
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title C: DTG 50 mg and 3TC 300 mg Bilayer FDC Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Overall Number of Participants Analyzed 16 16
Median (Full Range)
Unit of Measure: Percentage of AUC
DTG
3.6835
(1.069 to 8.601)
3.8790
(1.561 to 9.126)
3TC
1.0443
(0.467 to 3.859)
1.7467
(0.567 to 3.642)
47.Secondary Outcome
Title AUC(0-24) of DTG and 3TC in the Fed State: Part 1
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title B: DTG 50 mg/ 3TC 300 mg Monolayer FDC Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Overall Number of Participants Analyzed 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*microgram per milliliter
DTG
43.1879
(29.88%)
46.8555
(16.95%)
3TC
12.6113
(21.25%)
11.8076
(18.71%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B: DTG 50 mg/ 3TC 300 mg Monolayer FDC, Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.0849
Confidence Interval (2-Sided) 90%
0.9613 to 1.2245
Estimation Comments Ratio (Bfed/B) of plasma DTG has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection B: DTG 50 mg/ 3TC 300 mg Monolayer FDC, Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.9363
Confidence Interval (2-Sided) 90%
0.8913 to 0.9836
Estimation Comments Ratio (Bfed/B) of plasma 3TC has been presented
48.Secondary Outcome
Title AUC(0-24) of DTG and 3TC in the Fed State: Part 2
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title C: DTG 50 mg and 3TC 300 mg Bilayer FDC Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Overall Number of Participants Analyzed 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*microgram per milliliter
DTG
38.6325
(34.53%)
48.2012
(15.53%)
3TC
13.7012
(19.24%)
12.1065
(21.09%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C: DTG 50 mg and 3TC 300 mg Bilayer FDC, Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 1.2477
Confidence Interval (2-Sided) 90%
1.1013 to 1.4136
Estimation Comments Median Difference of plasma DTG has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection C: DTG 50 mg and 3TC 300 mg Bilayer FDC, Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.8836
Confidence Interval (2-Sided) 90%
0.8351 to 0.9350
Estimation Comments Median Difference of plasma 3TC has been presented
49.Secondary Outcome
Title CL/F of DTG and 3TC in the Fed State: Part 1
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title B: DTG 50 mg/ 3TC 300 mg Monolayer FDC Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Overall Number of Participants Analyzed 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters per hour
DTG
0.8020
(32.34%)
0.6947
(19.99%)
3TC
22.3285
(21.02%)
23.3159
(18.50%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B: DTG 50 mg/ 3TC 300 mg Monolayer FDC, Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.8661
Confidence Interval (2-Sided) 90%
0.7658 to 0.9796
Estimation Comments Ratio (Bfed/B) of plasma DTG has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection B: DTG 50 mg/ 3TC 300 mg Monolayer FDC, Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.0442
Confidence Interval (2-Sided) 90%
0.9951 to 1.0957
Estimation Comments Ratio (Bfed/B) of plasma 3TC has been presented
50.Secondary Outcome
Title CL/F of DTG and 3TC in the Fed State: Part 2
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title C: DTG 50 mg and 3TC 300 mg Bilayer FDC Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Overall Number of Participants Analyzed 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters per hour
DTG
0.8672
(35.93%)
0.6542
(22.36%)
3TC
20.4890
(18.50%)
22.4815
(20.34%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C: DTG 50 mg and 3TC 300 mg Bilayer FDC, Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.7544
Confidence Interval (2-Sided) 90%
0.6736 to 0.8448
Estimation Comments Ratio (Cfed/C) of plasma DTG has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection C: DTG 50 mg and 3TC 300 mg Bilayer FDC, Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.0972
Confidence Interval (2-Sided) 90%
1.0424 to 1.1550
Estimation Comments Ratio (Cfed/C) of plasma 3TC has been presented
51.Secondary Outcome
Title Tlast of DTG and 3TC in the Fed State: Part 1
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title B: DTG 50 mg/ 3TC 300 mg Monolayer FDC Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Overall Number of Participants Analyzed 16 16
Median (Full Range)
Unit of Measure: Hours
DTG
71.8265
(71.124 to 72.301)
71.9758
(71.330 to 72.869)
3TC
71.8265
(71.124 to 72.301)
71.9758
(71.330 to 72.869)
52.Secondary Outcome
Title Tlast of DTG and 3TC in the Fed State: Part 2
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title C: DTG 50 mg and 3TC 300 mg Bilayer FDC Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Overall Number of Participants Analyzed 16 16
Median (Full Range)
Unit of Measure: Hours
DTG
72.0292
(71.446 to 72.269)
71.8711
(71.080 to 72.381)
3TC
72.0292
(71.446 to 72.269)
71.8711
(71.080 to 72.381)
53.Secondary Outcome
Title Vz/F of DTG and 3TC in the Fed State: Part 1
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population.
Arm/Group Title B: DTG 50 mg/ 3TC 300 mg Monolayer FDC Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug.
Overall Number of Participants Analyzed 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters
DTG
16.7520
(28.45%)
14.4964
(15.87%)
3TC
593.2054
(29.23%)
643.0977
(41.08%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection B: DTG 50 mg/ 3TC 300 mg Monolayer FDC, Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.8654
Confidence Interval (2-Sided) 90%
0.7629 to 0.9816
Estimation Comments Ratio (Bfed/B) of plasma DTG has been presented
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection B: DTG 50 mg/ 3TC 300 mg Monolayer FDC, Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.0841
Confidence Interval (2-Sided) 90%
0.9139 to 1.2860
Estimation Comments Ratio (Bfed/B) of plasma 3TC has been presented
54.Secondary Outcome
Title Vz/F of DTG and 3TC in the Fed State: Part 2
Hide Description Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant’s first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
Time Frame Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Parameter FD Summary Population
Arm/Group Title C: DTG 50 mg and 3TC 300 mg Bilayer FDC Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Hide Arm/Group Description:
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug.
Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2.
Overall Number of Participants Analyzed 16 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters
DTG
19.0954
(36.45%)
14.6215
(11.63%)
3TC
535.8125
(35.63%)
641.3744
(32.10%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C: DTG 50 mg and 3TC 300 mg Bilayer FDC, Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
E