Bioequivalence of Empagliflozin/Metformin (12.5mg/500mg) Fixed Dose Combination Tablets Compared to Tablets Administered Together in Healthy Male and Female Volunteers Under Fed Conditions (an Open Label, Randomised, Single Dose, Two Period, Two Sequence Crossover Study)
Overview
- Phase
- Phase 1
- Intervention
- Empagliflozin/Metformin FDC
- Conditions
- Healthy
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- AUC (0-tz) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed dose combination tablets compared to tablets administered together in healthy male and female volunteers under fed conditions.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Fixed Dose Combination (FDC)
12.5 mg Empagliflozin / 500mg metformin fixed dose combination
Intervention: Empagliflozin/Metformin FDC
Separate tablets
Empagliflozin and Metformin tablets
Intervention: Empagliflozin 2.5 mg
Separate tablets
Empagliflozin and Metformin tablets
Intervention: Empagliflozin 10 mg
Separate tablets
Empagliflozin and Metformin tablets
Intervention: Metformin 500 mg
Outcomes
Primary Outcomes
AUC (0-tz) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)
Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
AUC (0-tz) (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point)
Cmax (Maximum Measured Concentration of Metformin in Plasma)
Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Cmax (maximum measured concentration of metformin in plasma)
Secondary Outcomes
- AUC (0-infinity) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity)(1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration)