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Bioequivalence Study Between SKF101804 Cefixime 200 Milligram (mg)/5 Milliliter (mL) Suspension Versus Cefixime 200 mg/5 mL Suspension Reference Product in Healthy Adult Subjects Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT03408392
Recruitment Status : Completed
First Posted : January 24, 2018
Results First Posted : March 22, 2019
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Infections, Bacterial
Interventions Drug: Test formulation A
Drug: Reference formulation B
Enrollment 28
Recruitment Details This was an open-label, randomized, single-dose, two-period cross-over study to evaluate bioequivalence of SKF101804 Cefixime 200 milligram (mg)/5 milliliter (mL) suspension versus Cefixime 200 mg/5 mL suspension reference product in healthy adult participants under fasting conditions. Participants were enrolled at a single center in South Africa.
Pre-assignment Details Participants received treatment in one of the two sequences; SKF101804 cefixime 200mg/5mL suspension (Test formulation) followed by cefixime 200mg/5mL suspension (Reference formulation)or vice versa in each of the treatment period 1 and 2. A total number of 28 participants were randomized.
Arm/Group Title SKF101804 Cefixime Followed by Cefixime Reference Formulation Cefixime Reference Formulation Followed by SKF101804 Cefixime
Hide Arm/Group Description Eligible participants received single dose of Test formulation (SKF101804 cefixime 200 mg /5 mL suspension) orally on Day 1 in Treatment period 1. It was followed by a washout period of at least 7 days and not more than 14 days. Participants received single dose of Reference formulation (cefixime 200 mg/5 mL suspension) orally on Day 1 in Treatment period 2. Eligible participants received single dose of Reference formulation (cefixime 200 mg/5 mL suspension) orally on Day 1 in Treatment period 1. It was followed by a washout period of at least 7 days and not more than 14 days. Participants received single dose of Test formulation (SKF101804 cefixime 200 mg /5 mL suspension) orally on Day 1 in Treatment period 2.
Period Title: Treatment Period 1 (16 Days)
Started 14 14
Completed 14 14
Not Completed 0 0
Period Title: Wash-out Period (14 Days)
Started 14 14
Completed 14 14
Not Completed 0 0
Period Title: Treatment Period 2 (16 Days)
Started 14 14
Completed 14 14
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description Eligible participants received a single dose of Test formulation (SKF101804 cefixime 200 mg /5 mL suspension) followed by Reference formulation (cefixime 200 mg/5 mL suspension) or vice versa, administered orally on Day 1 in each treatment period 1 and 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
28.9  (7.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
7
  25.0%
Male
21
  75.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Mixed Race
3
  10.7%
White/Caucasian/European Heritage
4
  14.3%
Black or African American
21
  75.0%
1.Primary Outcome
Title Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) for Cefixime
Hide Description Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods. Pharmacokinetic Population comprised of participants who completed the study and for whom primary pharmacokinetic parameters could be calculated for all treatment periods were included in the statistical pharmacokinetic analysis of the study.
Time Frame Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 28 28
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*nanogram per milliliter
20000
(32.9%)
19000
(34.3%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SKF101804 Cefixime, Cefixime Reference Formulation
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Bio-equivalence analysis comparing cefixime test and reference product has been presented.
Method of Estimation Estimation Parameter Percentage ratio
Estimated Value 105.38
Confidence Interval (2-Sided) 90%
96.11 to 115.54
Estimation Comments [Not Specified]
2.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) Within a Participant Across All Treatments of Cefixime
Hide Description Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.
Time Frame Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 28 28
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram per milliliter
2670
(29.4%)
2640
(30.5%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SKF101804 Cefixime, Cefixime Reference Formulation
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Bio-equivalence analysis comparing cefixime test and reference product has been presented.
Method of Estimation Estimation Parameter Percentage ratio
Estimated Value 101.14
Confidence Interval (2-Sided) 90%
93.37 to 109.55
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to (AUC [0-infinity]) Across All Treatments for Cefixime
Hide Description Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.
Time Frame Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 28 28
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*nanogram per milliliter
20700
(31.8%)
19700
(33.3%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SKF101804 Cefixime, Cefixime Reference Formulation
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Bio-equivalence analysis comparing cefixime test and reference product has been presented.
Method of Estimation Estimation Parameter Percentage ratio
Estimated Value 105.14
Confidence Interval (2-Sided) 90%
96.31 to 114.78
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time of Occurrence of Cmax (Tmax) for Cefixime
Hide Description Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Tmax of cefixime was analyzed using a nonparametric test to compute point estimate of the median and full range.
Time Frame Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 28 28
Median (Full Range)
Unit of Measure: Hours
4.005
(2.50 to 6.02)
4.005
(2.02 to 4.51)
5.Secondary Outcome
Title Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for Cefixime
Hide Description Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.
Time Frame Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 28 28
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Percentage of AUCex
3.24
(51.4%)
3.32
(67.8%)
6.Secondary Outcome
Title Terminal Phase Half-life (T1/2) for Cefixime
Hide Description Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.
Time Frame Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 28 28
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
3.18
(15.0%)
3.13
(14.7%)
7.Secondary Outcome
Title Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE)
Hide Description An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations. The analysis was performed on Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.
Time Frame Up to Day 16 in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 28 28
Measure Type: Count of Participants
Unit of Measure: Participants
Non-serious AEs
0
   0.0%
0
   0.0%
SAEs
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points
Hide Description Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including ALT, ALP and AST.
Time Frame Day -1 and Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Units per liter
ALT; Period 1; Day -1, 24 Hours Pre-dose 16.6  (10.23) 15.6  (5.67)
ALT; Period 1; Day 2, 24 Hours Post-dose 13.6  (7.09) 14.0  (5.76)
ALT; Period 2; Day -1, 24 Hours Pre-dose 16.4  (8.98) 16.7  (9.15)
ALT; Period 2; Day 2, 24 Hours Post-dose 14.1  (7.07) 14.9  (7.68)
ALP; Period 1; Day -1, 24 Hours Pre-dose 80.4  (12.85) 74.8  (18.25)
ALP; Period 1; Day 2, 24 Hours Post-dose 75.5  (14.27) 67.1  (15.23)
ALP; Period 2; Day -1, 24 Hours Pre-dose 72.4  (17.58) 80.9  (15.81)
ALP; Period 2; Day 2, 24 Hours Post-dose 69.7  (16.96) 76.9  (15.13)
AST; Period 1; Day -1, 24 Hours Pre-dose 20.9  (4.40) 20.6  (4.22)
AST; Period 1; Day 2, 24 Hours Post-dose 16.7  (2.64) 17.1  (3.45)
AST; Period 2; Day -1, 24 Hours Pre-dose 20.5  (6.00) 19.9  (4.57)
AST; Period 2; Day 2, 24 Hours Post-dose 16.8  (3.75) 17.8  (4.08)
9.Secondary Outcome
Title Blood Urea Nitrogen (BUN) at Indicated Time-points
Hide Description Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of BUN.
Time Frame Day -1 and Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Milligrams per deciliter
Period 1; Day -1, 24 Hours Pre-dose 10.354  (1.972) 10.300  (4.120)
Period 1; Day 2, 24 Hours Post-dose 12.945  (2.349) 12.258  (2.664)
Period 2; Day -1, 24 Hours Pre-dose 10.841  (3.571) 11.844  (2.017)
Period 2; Day 2, 24 Hours Post-dose 12.041  (2.166) 12.796  (1.599)
10.Secondary Outcome
Title Calcium, Glucose, Potassium and Sodium at Indicated Time-points
Hide Description Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including calcium, glucose, potassium and sodium.
Time Frame Day -1 and Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter
Calcium;Period 1;Day -1, 24 Hours Pre-dose 2.393  (0.059) 2.399  (0.134)
Calcium;Period 1;Day 2, 24 Hours Post-dose 2.308  (0.068) 2.304  (0.076)
Calcium;Period 2;Day -1, 24 Hours Pre-dose 2.364  (0.099) 2.376  (0.060)
Calcium;Period 2;Day 2, 24 Hours Post-dose 2.351  (0.087) 2.378  (0.081)
Glucose;Period 1;Day -1, 24 Hours Pre-dose 4.684  (0.256) 4.616  (0.267)
Glucose;Period 1;Day 2, 24 Hours Post-dose 4.728  (0.229) 4.676  (0.295)
Glucose;Period 2;Day -1, 24 Hours Pre-dose 4.521  (0.347) 4.571  (0.404)
Glucose;Period 2;Day 2, 24 Hours Post-dose 4.851  (0.375) 4.812  (0.278)
Sodium;Period 1;Day -1, 24 Hours Pre-dose 143.86  (1.460) 145.00  (1.414)
Sodium;Period 1;Day 2, 24 Hours Post-dose 141.07  (1.439) 141.43  (1.604)
Sodium;Period 2;Day -1, 24 Hours Pre-dose 141.21  (1.251) 141.50  (1.912)
Sodium;Period 2;Day 2, 24 Hours Post-dose 139.43  (1.089) 139.64  (1.550)
Potassium;Period1;Day -1, 24 Hours Pre-dose 4.634  (0.457) 4.404  (0.316)
Potassium;Period1;Day 2, 24 Hours Post-dose 4.522  (0.444) 4.286  (0.206)
Potassium;Period 2;Day -1, 24 Hours Pre-dose 4.371  (0.220) 4.521  (0.346)
Potassium;Period 2;Day 2, 24 Hours Post-dose 4.269  (0.334) 4.555  (0.402)
11.Secondary Outcome
Title Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points
Hide Description Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including total bil, direct bil and creat.
Time Frame Day -1 and Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Micromoles per liter
Creat; Period 1; Day -1, 24 Hours Pre-dose 82.4  (15.29) 83.4  (15.45)
Creat; Period 1; Day 2, 24 Hours Post-dose 79.9  (12.00) 85.9  (15.59)
Creat; Period 2; Day -1, 24 Hours Pre-dose 81.1  (14.31) 78.5  (14.21)
Creat; Period 2; Day 2, 24 Hours Post-dose 83.9  (15.33) 78.4  (12.71)
Total bil; Period1;Day -1, 24 Hours Pre-dose 10.14  (4.633) 10.99  (6.235)
Total bil; Period1;Day 2, 24 Hours Post-dose 6.83  (3.004) 8.10  (6.191)
Total bil; Period2;Day -1, 24 Hours Pre-dose 9.90  (7.205) 8.22  (3.516)
Total bil; Period2;Day 2, 24 Hours Post-dose 6.47  (3.749) 6.16  (2.843)
Direct bil; Period1;Day -1, 24 Hours Pre-dose 3.68  (1.294) 4.01  (1.794)
Direct bil; Period1;Day 2, 24 Hours Post-dose 2.65  (0.959) 2.93  (1.630)
Direct bil; Period2;Day -1, 24 Hours Pre-dose 3.58  (1.945) 3.12  (1.057)
Direct bil; Period2;Day 2, 24 Hours Post-dose 2.55  (1.149) 2.49  (0.972)
12.Secondary Outcome
Title Total Protein at Indicated Time-points
Hide Description Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of total Protein.
Time Frame Day -1 and Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Grams per liter
Period 1; Day -1, 24 Hours Pre-dose 74.34  (3.354) 74.77  (4.725)
Period 1; Day 2, 24 Hours Post-dose 67.90  (3.295) 67.97  (2.635)
Period 2; Day -1, 24 Hours Pre-dose 73.76  (3.995) 72.57  (3.886)
Period 2; Day 2, 24 Hours Post-dose 67.64  (3.181) 67.89  (4.211)
13.Secondary Outcome
Title Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points
Hide Description Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including platelets, neutrophils, monocytes, lymphocytes, leucocyte, eosinophils and basophils.
Time Frame Day -1 and Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: 10^9 cells per liter
Basophil; Period 1;Day -1, 24 Hours Pre-dose 0.023  (0.017) 0.022  (0.013)
Basophil; Period 1;Day 2, 24 Hours Post-dose 0.024  (0.012) 0.025  (0.011)
Basophil; Period 2;Day -1, 24 Hours Pre-dose 0.026  (0.012) 0.029  (0.025)
Basophil; Period 2;Day 2, 24 Hours Post-dose 0.024  (0.012) 0.022  (0.026)
Eosinophil; Period 1;Day-1, 24 Hours Pre-dose 0.136  (0.130) 0.182  (0.157)
Eosinophil; Period 1;Day 2, 24 Hours Post-dose 0.146  (0.130) 0.204  (0.199)
Eosinophil; Period 2; Day -1, 24 Hours Pre-dose 0.231  (0.230) 0.139  (0.144)
Eosinophil; Period 2; Day 2, 24 Hours Post-dose 0.253  (0.245) 0.156  (0.182)
Leucocyte; Period 1;Day-1,24 Hours Pre-dose 5.458  (1.643) 5.752  (0.907)
Leucocyte; Period 1;Day 2,24 Hours Post-dose 5.369  (1.535) 5.394  (1.019)
Leucocyte; Period 2;Day -1,24 Hours Pre-dose 5.736  (1.168) 5.463  (1.388)
Leucocyte; Period 2;Day 2,24 Hours Post-dose 5.887  (1.216) 5.477  (1.571)
Lymphocyte; Period 1;Day -1,24 Hours Pre-dose 2.127  (0.562) 2.154  (0.493)
Lymphocyte; Period 1;Day 2,24 Hours Post-dose 1.916  (0.453) 2.039  (0.459)
Lymphocyte; Period 2;Day -1,24 Hours Pre-dose 2.328  (0.573) 2.141  (0.409)
Lymphocyte; Period 2;Day 2,24 Hours Post-dose 2.186  (0.431) 1.956  (0.486)
Monocytes; Period 1;Day -1,24 Hours Pre-dose 0.480  (0.123) 0.470  (0.127)
Monocytes; Period 1;Day 2,24 Hours Post-dose 0.464  (0.142) 0.459  (0.125)
Monocytes; Period 2;Day -1,24 Hours Pre-dose 0.461  (0.146) 0.497  (0.126)
Monocytes; Period 2;Day 2,24 Hours Post-dose 0.475  (0.160) 0.457  (0.122)
Neutrophils;Period 1;Day -1,24 Hours Pre-dose 2.692  (1.293) 2.924  (0.706)
Neutrophils;Period 1;Day 2,24 Hours Post-dose 2.820  (1.289) 2.667  (0.667)
Neutrophils;Period 2;Day -1,24 Hours Pre-dose 2.691  (0.697) 2.657  (1.162)
Neutrophils;Period 2;Day 2,24 Hours Post-dose 2.949  (0.848) 2.885  (1.204)
Platelet; Period 1;Day -1,24 Hours Pre-dose 288.9  (61.98) 264.4  (60.63)
Platelet; Period 1;Day 2,24 Hours Post-dose 281.2  (65.74) 244.5  (64.60)
Platelet; Period 2;Day -1,24 Hours Pre-dose 264.6  (61.65) 289.6  (72.29)
Platelet; Period 2;Day 2,24 Hours Post-dose 245.0  (56.04) 274.2  (68.61)
14.Secondary Outcome
Title Mean Corpuscular Volume (MCV) at Indicated Time-points
Hide Description Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCV.
Time Frame Day -1 and Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Femtoliter
Period 1; Day -1, 24 Hours Pre-dose 85.73  (2.834) 84.86  (4.946)
Period 1; Day 2, 24 Hours Post-dose 85.30  (2.796) 84.50  (4.895)
Period 2; Day -1, 24 Hours Pre-dose 84.83  (4.975) 85.97  (2.903)
Period 2; Day 2, 24 Hours Post-dose 84.46  (4.878) 85.41  (2.847)
15.Secondary Outcome
Title Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points
Hide Description Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCH.
Time Frame Day -1 and Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Picogram
Period 1; Day -1, 24 Hours Pre-dose 29.58  (1.212) 29.44  (2.140)
Period 1; Day 2, 24 Hours Post-dose 29.75  (1.295) 29.51  (2.190)
Period 2; Day -1, 24 Hours Pre-dose 29.40  (2.242) 29.68  (1.207)
Period 2; Day 2, 24 Hours Post-dose 29.54  (2.112) 29.75  (1.320)
16.Secondary Outcome
Title Erythrocyte Count at Indicated Time-points
Hide Description Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of erythrocyte count.
Time Frame Day -1 and Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: 10^12 cells per liter
Period 1; Day -1, 24 Hours Pre-dose 5.104  (0.451) 5.020  (0.480)
Period 1; Day 2, 24 Hours Post-dose 4.952  (0.387) 4.871  (0.424)
Period 2; Day -1, 24 Hours Pre-dose 5.006  (0.366) 4.971  (0.473)
Period 2; Day 2, 24 Hours Post-dose 4.838  (0.433) 4.906  (0.494)
17.Secondary Outcome
Title Hematocrit at Indicated Time-points
Hide Description Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematocrit.
Time Frame Day -1 and Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Proportion of red blood cells in blood
Period 1; Day -1, 24 Hours Pre-dose 0.437  (0.036) 0.426  (0.043)
Period 1; Day 2, 24 Hours Post-dose 0.422  (0.033) 0.411  (0.038)
Period 2; Day -1, 24 Hours Pre-dose 0.424  (0.029) 0.427  (0.040)
Period 2; Day 2, 24 Hours Post-dose 0.408  (0.036) 0.419  (0.041)
18.Secondary Outcome
Title Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points
Hide Description Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including MCHC and Hb.
Time Frame Day -1 and Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Grams per deciliter
MCHC; Period 1; Day -1, 24 Hours Pre-dose 34.52  (1.030) 34.68  (0.957)
MCHC; Period 1; Day 2, 24 Hours Post-dose 34.88  (1.084) 34.89  (1.100)
MCHC; Period 2; Day -1, 24 Hours Pre-dose 34.64  (1.100) 34.54  (0.880)
MCHC; Period 2; Day 2, 24 Hours Post-dose 34.95  (1.097) 34.82  (1.062)
Hb; Period 1;Day -1, 24 Hours Pre-dose 15.11  (1.554) 14.79  (1.833)
Hb; Period 1;Day 2, 24 Hours Post-dose 14.74  (1.391) 14.38  (1.623)
Hb; Period 2;Day -1, 24 Hours Pre-dose 14.70  (1.381) 14.76  (1.591)
Hb; Period 2;Day 2, 24 Hours Post-dose 14.29  (1.578) 14.60  (1.708)
19.Secondary Outcome
Title Percent Reticulocytes at Indicated Time-points
Hide Description Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of percent reticulocytes.
Time Frame Day -1 and Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Percentage of reticulocytes
Period 1; Day -1, 24 Hours Pre-dose 1.786  (0.361) 1.700  (0.346)
Period 1; Day 2, 24 Hours Post-dose 1.757  (0.384) 1.571  (0.297)
Period 2; Day -1, 24 Hours Pre-dose 1.729  (0.397) 1.886  (0.335)
Period 2; Day 2, 24 Hours Post-dose 2.350  (2.176) 1.743  (0.361)
20.Secondary Outcome
Title Number of Participants With Potential Clinical Importance (PCI) Abnormal Findings for Urinalysis
Hide Description Urine samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2. PCI ranges for urinalysis parameters were as follows: specific gravity 1.001 to 1.035 kilogram per liter, blood negative (0 to 9) RBC per microliter, pH 4.6 to 8.0, protein negative (0.0 to 0.14) gram per liter, glucose negative (0 to 5.49) millimoles per liter, ketones negative (0.0 to 0.49) millimoles per liter, urobilinogen (0.0 to 1.0) milligrams per deciliter, urine leucocytes negative (0 to 14) leucocytes per microliter, Urine WBC, RBC and epithelial cells 0 to 5 high power per field.
Time Frame Day -1 and Day 2 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 14 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
21.Secondary Outcome
Title Respiratory Rate at Indicated Time-points
Hide Description Respiratory rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.
Time Frame Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Breaths per minute
Period 1; Day 1, 1.5 Hours Pre-dose 15.0  (1.11) 15.7  (0.73)
Period 1; Day 1, 2 Hours Post-dose 17.3  (2.02) 17.0  (2.69)
Period 1; Day 1, 4 Hours Post-dose 15.5  (2.10) 14.2  (1.25)
Period 1; Day 1, 6 Hours Post-dose 15.0  (2.00) 14.8  (0.97)
Period 1; Day 2, 24 Hours Post-dose 15.9  (2.14) 16.1  (2.95)
Period 2; Day 1, 1.5 Hours Pre-dose 15.8  (1.19) 15.6  (0.74)
Period 2; Day 1, 2 Hours Post-dose 18.4  (1.65) 18.2  (1.72)
Period 2; Day 1, 4 Hours Post-dose 16.7  (3.10) 18.4  (1.65)
Period 2; Day 1, 6 Hours Post-dose 17.9  (1.46) 19.0  (1.04)
Period 2; Day 2, 24 Hours Post-dose 16.2  (1.25) 16.0  (2.22)
22.Secondary Outcome
Title Pulse Rate at Indicated Time-points
Hide Description Pulse rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.
Time Frame Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Period 1; Day 1, 1.5 Hours Pre-dose 67.0  (7.95) 58.1  (8.76)
Period 1; Day 1, 2 Hours Post-dose 61.0  (8.17) 55.1  (8.32)
Period 1; Day 1, 4 Hours Post-dose 61.9  (7.44) 55.6  (7.49)
Period 1; Day 1, 6 Hours Post-dose 75.0  (8.74) 67.2  (12.97)
Period 1; Day 2, 24 Hours Post-dose 66.5  (10.26) 54.3  (7.22)
Period 2; Day 1, 1.5 Hours Pre-dose 57.9  (9.08) 65.1  (6.85)
Period 2; Day 1, 2 Hours Post-dose 54.1  (8.88) 63.1  (8.87)
Period 2; Day 1, 4 Hours Post-dose 56.6  (8.67) 62.8  (7.92)
Period 2; Day 1, 6 Hours Post-dose 68.5  (14.09) 75.1  (8.82)
Period 2; Day 2, 24 Hours Post-dose 59.2  (7.59) 67.1  (8.62)
23.Secondary Outcome
Title Body Temperature at Indicated Time-points
Hide Description Body temperature of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.
Time Frame Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Degree Celsius
Period 1; Day 1, 1.5 Hours Pre-dose 36.19  (0.305) 36.27  (0.336)
Period 1; Day 1, 2 Hours Post-dose 36.38  (0.333) 36.23  (0.261)
Period 1; Day 1, 4 Hours Post-dose 36.48  (0.336) 36.59  (0.352)
Period 1; Day 1, 6 Hours Post-dose 36.64  (0.303) 36.79  (0.202)
Period 1; Day 2, 24 Hours Post-dose 36.29  (0.317) 36.24  (0.365)
Period 2; Day 1, 1.5 Hours Pre-dose 36.28  (0.372) 36.29  (0.317)
Period 2; Day 1, 2 Hours Post-dose 36.51  (0.400) 36.42  (0.404)
Period 2; Day 1, 4 Hours Post-dose 36.58  (0.347) 36.51  (0.243)
Period 2; Day 1, 6 Hours Post-dose 36.10  (0.421) 36.63  (0.300)
Period 2; Day 2, 24 Hours Post-dose 36.30  (0.321) 36.11  (0.434)
24.Secondary Outcome
Title Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points
Hide Description Blood pressure of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.
Time Frame Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description:
Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury
SBP, Period 1; Day 1, 1.5 Hours Pre-dose 110.6  (8.22) 110.9  (6.39)
SBP, Period 1; Day 1, 2 Hours Post-dose 113.4  (7.30) 111.3  (8.68)
SBP, Period 1; Day 1, 4 Hours Post-dose 112.3  (8.39) 112.1  (4.25)
SBP, Period 1; Day 1, 6 Hours Post-dose 111.6  (7.17) 108.6  (6.46)
SBP, Period 1; Day 2, 24 Hours Post-dose 110.9  (6.86) 115.4  (7.00)
SBP, Period 2; Day 1, 1.5 Hours Pre-dose 110.4  (3.97) 111.2  (10.09)
SBP, Period 2; Day 1, 2 Hours Post-dose 113.1  (6.24) 112.7  (10.94)
SBP, Period 2; Day 1, 4 Hours Post-dose 112.6  (8.53) 111.1  (9.79)
SBP, Period 2; Day 1, 6 Hours Post-dose 109.6  (7.14) 109.5  (8.98)
SBP, Period 2; Day 2, 24 Hours Post-dose 113.1  (6.24) 113.6  (9.05)
DBP, Period 1; Day 1, 1.5 Hours Pre-dose 62.9  (6.59) 64.1  (7.76)
DBP, Period 1; Day 1, 2 Hours Post-dose 62.9  (7.69) 60.9  (6.38)
DBP, Period 1; Day 1, 4 Hours Post-dose 62.5  (5.43) 63.3  (6.94)
DBP, Period 1; Day 1, 6 Hours Post-dose 59.3  (3.89) 59.6  (5.09)
DBP, Period 1; Day 2, 24 Hours Post-dose 63.0  (6.80) 66.2  (7.65)
DBP, Period 2; Day 1, 1.5 Hours Pre-dose 111.2  (10.09) 61.8  (7.20)
DBP, Period 2; Day 1, 2 Hours Post-dose 66.2  (7.65) 63.1  (9.12)
DBP, Period 2; Day 1, 4 Hours Post-dose 63.5  (8.55) 62.6  (8.21)
DBP, Period 2; Day 1, 6 Hours Post-dose 59.4  (4.97) 60.2  (7.79)
DBP, Period 2; Day 2, 24 Hours Post-dose 63.9  (7.41) 67.7  (7.90)
Time Frame Serious adverse events (SAEs) and Non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to Day 16 in each treatment period.
Adverse Event Reporting Description SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment.
 
Arm/Group Title SKF101804 Cefixime Cefixime Reference Formulation
Hide Arm/Group Description Eligible participants received SKF101804 cefixime 200mg/5mL suspension (Test formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods. Eligible participants received Cefixime 200mg/5mL suspension (Reference formulation), administered orally on Day 1 in each treatment period 1 or 2. The washout period was of at least 7 days and not more than 14 days between the treatment periods.
All-Cause Mortality
SKF101804 Cefixime Cefixime Reference Formulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Hide Serious Adverse Events
SKF101804 Cefixime Cefixime Reference Formulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SKF101804 Cefixime Cefixime Reference Formulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03408392    
Other Study ID Numbers: 205731
First Submitted: January 17, 2018
First Posted: January 24, 2018
Results First Submitted: December 11, 2018
Results First Posted: March 22, 2019
Last Update Posted: February 25, 2020