Bioequivalence of Empagliflozin/Metformin (500 mg) Fixed Dose Combination Tablets Compared to Single Tablets Administered Together in Healthy Male and Female Volunteers Under Fed Conditions (an Open-label, Randomised, Single-dose, Four-way Crossover Study)
Overview
- Phase
- Phase 1
- Intervention
- empagliflozin and metformin
- Conditions
- Healthy
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- AUC0-∞ for Empagliflozin
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
FDC empagliflozin dose 1 and metformin
fix dose combination tablet after intake of a high fat, high caloric meal
Intervention: empagliflozin and metformin
empagliflozin dose 1 + metformin tablets
single tablets after intake of a high fat, high caloric meal
Intervention: empagliflozin
empagliflozin dose 1 + metformin tablets
single tablets after intake of a high fat, high caloric meal
Intervention: metformin (Glucophage®)
FDC empagliflozin dose 2 and metformin
fix dose combination tablet after intake of a high fat, high caloric meal
Intervention: empagliflozin and metformin
empagliflozin dose 2 + metformin tablets
single tablets after intake of a high fat, high caloric meal
Intervention: metformin (Glucophage®)
empagliflozin dose 2 + metformin tablets
single tablets after intake of a high fat, high caloric meal
Intervention: empagliflozin
Outcomes
Primary Outcomes
AUC0-∞ for Empagliflozin
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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 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)