Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01844531
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this trial is to establish bioequivalence of two fixed dose combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin \[Test 1\] and low dose empagliflozin/500 mg metformin \[Test 2\]) and of the single tablets (medium dose empagliflozin tablets + Glucophage® 500 mg tablet \[Reference 1\] and low dose empagliflozin tablet + Glucophage® 500 mg tablet \[Reference 2\]) when administered together after a high fat, high caloric meal.
The assessment of safety and tolerability will be an additional objective of this trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description FDC empagliflozin dose 1 and metformin empagliflozin and metformin fix dose combination tablet after intake of a high fat, high caloric meal empagliflozin dose 1 + metformin tablets empagliflozin single tablets after intake of a high fat, high caloric meal empagliflozin dose 1 + metformin tablets metformin (Glucophage®) single tablets after intake of a high fat, high caloric meal FDC empagliflozin dose 2 and metformin empagliflozin and metformin fix dose combination tablet after intake of a high fat, high caloric meal empagliflozin dose 2 + metformin tablets metformin (Glucophage®) single tablets after intake of a high fat, high caloric meal empagliflozin dose 2 + metformin tablets empagliflozin single tablets after intake of a high fat, high caloric meal
- Primary Outcome Measures
Name Time Method AUC0-∞ for Empagliflozin 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Empagliflozin
AUC0-∞ for Metformin 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Metformin
Cmax for Empagliflozin 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake Cmax (maximum measured concentration of the analyte in plasma) for Empagliflozin
Cmax for Metformin 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake Cmax (maximum measured concentration of the analyte in plasma) for Metformin
- Secondary Outcome Measures
Name Time Method AUC0-tz for Empagliflozin 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for Empagliflozin
AUC0-tz for Metformin 1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for Metformin
Trial Locations
- Locations (1)
1276.6.1 Boehringer Ingelheim Investigational Site
🇩🇪Biberach, Germany