Bioequivalence of Empagliflozin/Metformin (850 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 + Metformin
- Conditions
- Healthy
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The primary objective of this trial is to establish bioequivalence of two FDC tablets and the single tablets when administered together after a high fat high caloric meal.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Test 1
fixed dose combination tablet
Intervention: Empagliflozin + Metformin
Reference 1
empagliflozin tablets and metformin tablet
Intervention: Empagliflozin
Reference 1
empagliflozin tablets and metformin tablet
Intervention: Metformin
Test 2
fixed dose combination tablet
Intervention: Empagliflozin + Metformin
Reference 2
empagliflozin tablet and metformin tablet
Intervention: Metformin
Reference 2
empagliflozin tablet and metformin tablet
Intervention: Empagliflozin
Outcomes
Primary Outcomes
Empa: Area Under the Curve 0 to Infinity (AUC0-∞)
Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)
Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Empa: Maximum Measured Concentration (Cmax)
Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Maximum measured concentration of the analyte in plasma, per period. In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Metformin: Maximum Measured Concentration (Cmax)
Time Frame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Maximum measured concentration of the analyte in plasma, per period. In this endpoint, the "Measured values" shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Secondary Outcomes
- Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)(1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration)
- Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)(1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration)