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Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Linagliptin Compared With the Free Combination of Empagliflozin Tablet and Linagliptin Tablet in Healthy Male and Female Subjects

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ClinicalTrials.gov Identifier: NCT02758171
Recruitment Status : Completed
First Posted : May 2, 2016
Results First Posted : November 22, 2017
Last Update Posted : November 22, 2017
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: Empagliflozin
Drug: Linagliptin
Enrollment 56
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FDC/Empagliflozin+Linagliptin Empagliflozin+Linagliptin/FDC
Hide Arm/Group Description

The subjects were administered one FDC (Fixed-Dose Combination) film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T) in period 1, followed by one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) administered orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R) in period 2.

A wash-out period of at least 35 days was set following the drug administration in each period.

The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R) in period 1, followed by one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin administered orally with 240 mL of water after an overnight fast of at least 10 h, as a single dose in the fasted state on Day 1 of Test treatment (T) in period 2.

A wash-out period of at least 35 days was set following the drug administration in each period.

Period Title: Treatment Period 1
Started 28 28
Completed 28 28
Not Completed 0 0
Period Title: Wash-out
Started 28 28
Completed 26 28
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             1             0
Other reason             1             0
Period Title: Treatment Period 2
Started 26 28
Completed 26 28
Not Completed 0 0
Arm/Group Title FDC/Empagliflozin+Linagliptin Empagliflozin+Linagliptin/FDC Total
Hide Arm/Group Description

The subjects were administered one FDC (Fixed-Dose Combination) film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T) in period 1, followed by one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) administered orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R) in period 2.

A wash-out period of at least 35 days was set following the drug administration in each period.

The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R) in period 1, followed by one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin administered orally with 240 mL of water after an overnight fast of at least 10 h, as a single dose in the fasted state on Day 1 of Test treatment (T) in period 2.

A wash-out period of at least 35 days was set following the drug administration in each period.

Total of all reporting groups
Overall Number of Baseline Participants 28 28 56
Hide Baseline Analysis Population Description
Treated Set (TS): This subject set included all subjects from the Randomised Set (RS) [ included all randomised subjects, whether treated or not] who were documented to have received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 28 participants 56 participants
39.1  (9.7) 38.9  (10.2) 39.0  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
Female
19
  67.9%
18
  64.3%
37
  66.1%
Male
9
  32.1%
10
  35.7%
19
  33.9%
1.Primary Outcome
Title AUC0-tz (Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)
Hide Description

This outcome measure presents area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 to the last quantifiable data point.

Time frame description: The time -1:00 hour (h) was approximate; the procedure was to be performed and completed within 2h before drug administration. PKS including participants with available data for AUC0-tz (area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 to the last quantifiable data point).

Time Frame 1:00 [hour (h): minute] before drug administration and 0:20h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, and 72:00h after drug administration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PharmacoKinetic parameter analysis Set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.
Arm/Group Title FDC (10 mg Empagliflozin and 5 mg Linagliptin) Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets
Hide Arm/Group Description:
The subjects were administered one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T).
The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R).
Overall Number of Participants Analyzed 55 54
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
2550
(18.0%)
2510
(19.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FDC (10 mg Empagliflozin and 5 mg Linagliptin), Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets
Comments The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence acceptable range of 80.00% to 125.00%.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted geometric mean (gMean) ratio
Estimated Value 101.71
Confidence Interval (2-Sided) 90%
99.818 to 103.644
Parameter Dispersion
Type: Standard Deviation
Value: 5.8
Estimation Comments

The ratio [%] calculated as T [FDC (10 mg Empagliflozin and 5 mg Linagliptin)]/R [Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets].

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

2.Primary Outcome
Title AUC0-72 (Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours)
Hide Description

This outcome measure presents area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 to 72 hours.

Time frame description: The time -1:00h was approximate; the procedure was to be performed and completed within 2h before drug administration. PKS including participants with available data for AUC0-72 (area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 to 72 hours).

Time Frame 1:00 [hour (h): minute] before drug administration and 0:20h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, and 72:00h after drug administration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PharmacoKinetic parameter analysis Set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.
Arm/Group Title FDC (10 mg Empagliflozin and 5 mg Linagliptin) Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets
Hide Arm/Group Description:
The subjects were administered one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T).
The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R).
Overall Number of Participants Analyzed 55 54
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
281
(22.5%)
283
(23.3%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FDC (10 mg Empagliflozin and 5 mg Linagliptin), Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets
Comments The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence acceptable range of 80.00% to 125.00%.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted geometric mean (gMean) ratio
Estimated Value 99.39
Confidence Interval (2-Sided) 90%
95.290 to 103.672
Parameter Dispersion
Type: Standard Deviation
Value: 13.1
Estimation Comments

The ratio [%] calculated as T [FDC (10 mg Empagliflozin and 5 mg Linagliptin)]/R [Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets].

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

3.Primary Outcome
Title Cmax (Maximum Measured Concentration of Empagliflozin Analyte in Plasma)
Hide Description

This outcome measure presents maximum measured concentration of Empagliflozin analyte in plasma.

Time frame description: The time -1:00h was approximate; the procedure was to be performed and completed within 2h before drug administration. PKS including participants with available data for Cmax (maximum measured concentration of Empagliflozin analyte in plasma).

Time Frame 1:00 [hour (h): minute] before drug administration and 0:20h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, and 72:00h after drug administration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PharmacoKinetic parameter analysis Set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.
Arm/Group Title FDC (10 mg Empagliflozin and 5 mg Linagliptin) Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets
Hide Arm/Group Description:
The subjects were administered one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T).
The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R).
Overall Number of Participants Analyzed 55 54
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
370
(23.9%)
365
(23.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FDC (10 mg Empagliflozin and 5 mg Linagliptin), Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets
Comments The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence acceptable range of 80.00% to 125.00%.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted geometric mean (gMean) ratio
Estimated Value 102.33
Confidence Interval (2-Sided) 90%
97.945 to 106.910
Parameter Dispersion
Type: Standard Deviation
Value: 13.6
Estimation Comments

The ratio [%] calculated as T [FDC (10 mg Empagliflozin and 5 mg Linagliptin)]/R [Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets].

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

4.Primary Outcome
Title Cmax (Maximum Measured Concentration of Linagliptin Analyte in Plasma)
Hide Description

This outcome measure presents maximum measured concentration of Linagliptin analyte in plasma.

Time frame description: The time -1:00h was approximate; the procedure was to be performed and completed within 2h before drug administration. PKS including participants with available data for Cmax (maximum measured concentration of Linagliptin analyte in plasma).

Time Frame 1:00 [hour (h): minute] before drug administration and 0:20h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, and 72:00h after drug administration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PharmacoKinetic parameter analysis Set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.
Arm/Group Title FDC (10 mg Empagliflozin and 5 mg Linagliptin) Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets
Hide Arm/Group Description:
The subjects were administered one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T).
The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R).
Overall Number of Participants Analyzed 55 54
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
9.33
(36.2%)
8.73
(37.1%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FDC (10 mg Empagliflozin and 5 mg Linagliptin), Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets
Comments The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence acceptable range of 80.00% to 125.00%.
Statistical Test of Hypothesis P-Value 0.0027
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted geometric mean (gMean) ratio
Estimated Value 107.51
Confidence Interval (2-Sided) 90%
98.561 to 117.282
Parameter Dispersion
Type: Standard Deviation
Value: 27.4
Estimation Comments

The ratio [%] calculated as T [FDC (10 mg Empagliflozin and 5 mg Linagliptin)]/R [Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets].

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

5.Secondary Outcome
Title AUC0-infinity (Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Hide Description

This outcome measure presents area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 extrapolated to infinity.

Time frame description: The time -1:00h was approximate; the procedure was to be performed and completed within 2h before drug administration. PKS including participants with available data for AUC0-infinity (area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 extrapolated to infinity).

Time Frame 1:00 [hour (h): minute] before drug administration and 0:20h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, and 72:00h after drug administration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PharmacoKinetic parameter analysis Set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.
Arm/Group Title FDC (10 mg Empagliflozin and 5 mg Linagliptin) Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets
Hide Arm/Group Description:
The subjects were administered one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T).
The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R).
Overall Number of Participants Analyzed 55 54
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
2580
(18.0%)
2550
(19.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FDC (10 mg Empagliflozin and 5 mg Linagliptin), Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets
Comments The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted geometric mean (gMean) ratio
Estimated Value 101.44
Confidence Interval (2-Sided) 90%
99.574 to 103.336
Parameter Dispersion
Type: Standard Deviation
Value: 5.7
Estimation Comments

The ratio [%] calculated as T [FDC (10 mg Empagliflozin and 5 mg Linagliptin)]/R [Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets].

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

6.Secondary Outcome
Title AUC0-infinity (Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Hide Description

This outcome measure presents area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 extrapolated to infinity.

Time frame description: The time -1:00h was approximate; the procedure was to be performed and completed within 2h before drug administration. PKS including participants with available data for (area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 extrapolated to infinity).

Time Frame 1:00 [hour (h): minute] before drug administration and 0:20h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, and 72:00h after drug administration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PharmacoKinetic parameter analysis Set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.
Arm/Group Title FDC (10 mg Empagliflozin and 5 mg Linagliptin) Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets
Hide Arm/Group Description:
The subjects were administered one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T).
The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R).
Overall Number of Participants Analyzed 55 54
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
451
(25.9%)
462
(29.2%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FDC (10 mg Empagliflozin and 5 mg Linagliptin), Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets
Comments The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted geometric mean (gMean) ratio
Estimated Value 98.15
Confidence Interval (2-Sided) 90%
93.456 to 103.082
Parameter Dispersion
Type: Standard Deviation
Value: 15.2
Estimation Comments

The ratio [%] calculated as T [FDC (10 mg Empagliflozin and 5 mg Linagliptin)]/R [Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets].

Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%].

Time Frame From first drug administration until 1 day after last drug administration, up to 77 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FDC (10 mg Empagliflozin and 5 mg Linagliptin) Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets
Hide Arm/Group Description The subjects were administered one FDC film-coated tablet containing 10 mg Empagliflozin and 5 mg Linagliptin orally with 240 mL of water after an overnight fast of at least 10 hours (h), as a single dose in the fasted state on Day 1 of Test treatment (T). The subjects were administered one film-coated tablet containing 10 mg Empagliflozin (reference product 1) in combination with 1 film-coated tablet containing 5 mg Linagliptin (reference product 2) orally with 240 mL of water after an overnight fast of at least 10 h, as single doses in the fasted state on Day 1 of Reference treatment (R).
All-Cause Mortality
FDC (10 mg Empagliflozin and 5 mg Linagliptin) Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FDC (10 mg Empagliflozin and 5 mg Linagliptin) Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/54 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FDC (10 mg Empagliflozin and 5 mg Linagliptin) Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   8/56 (14.29%)   7/54 (12.96%) 
Nervous system disorders     
Headache  1  8/56 (14.29%)  7/54 (12.96%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02758171     History of Changes
Other Study ID Numbers: 1275.21
2015-004234-98 ( EudraCT Number )
First Submitted: April 29, 2016
First Posted: May 2, 2016
Results First Submitted: June 22, 2017
Results First Posted: November 22, 2017
Last Update Posted: November 22, 2017