Bioequivalence of Empagliflozin/Metformin Fixed Dose Combination Tablets Compared to Single Tablets Administered Together in Healthy Male and Female Volunteers Under Fed and Fasted Conditions (an Open-label, Randomised, Single-dose, Crossover Study)
Overview
- Phase
- Phase 1
- Intervention
- Empagliflozin/Metformin
- Conditions
- Healthy
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets empagliflozin and metformin under fed conditions (Part II).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1 Empagliflozin/Metformin (T)
fixed-dose-combination tablet, oral with 240 ml water under fasted conditions
Intervention: Empagliflozin/Metformin
2 Empagliflozin/Metformin (T)
fixed-dose-combination tablet, oral with 240 ml water under fed conditions
Intervention: Empagliflozin/Metformin
3 Empagliflozin + Metformin (R)
tablets, oral with 240 ml water under fasted conditions
Intervention: Empagliflozin
3 Empagliflozin + Metformin (R)
tablets, oral with 240 ml water under fasted conditions
Intervention: Metformin
4 Empagliflozin + Metformin (R)
tablets, oral with 240 ml water under fed conditions
Intervention: Empagliflozin
4 Empagliflozin + Metformin (R)
tablets, oral with 240 ml water under fed conditions
Intervention: Metformin
5 Empagliflozin/Metformin (T)
fixed-dose-combination tablet, oral with 240 ml water under fed conditions
Intervention: Empagliflozin/Metformin
6 Empagliflozin + Metformin (R)
tablets, oral with 240 ml water under fed conditions
Intervention: Empagliflozin
6 Empagliflozin + Metformin (R)
tablets, oral with 240 ml water under fed conditions
Intervention: Metformin
Outcomes
Primary Outcomes
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin
Time Frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Empagliflozin
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Metformin
Time Frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Metformin
Maximum Measured Concentration of the Analyte in Plasma, Empagliflozin
Time Frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Cmax: maximum measured concentration of the analyte in plasma for Empagliflozin
Maximum Measured Concentration of the Analyte in Plasma, Metformin
Time Frame: 1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Cmax: maximum measured concentration of the analyte in plasma for Metformin
Secondary Outcomes
- Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Empagliflozin(1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 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 to the Last Quantifiable Data Point, Metformin(1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration)