Bioequivalence of a FDC Tablet of Linagliptin/Metformin (5mg/1000mg) Extended Release in Healthy Subjects
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02084082
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release, both under fed and fasted conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description FDC first, fed Metformin ER Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fed condition FDC first, fasted Metformin ER Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fasted condition FDC first, fasted Linagliptin/Metformin ER FDC Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fasted condition Single tablets first, fasted Metformin ER single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fasted condition FDC first, fed Linagliptin/Metformin ER FDC Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fed condition Single tablets first, fed Linagliptin single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fed condition FDC first, fed Linagliptin Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fed condition Single tablets first, fed Linagliptin/Metformin ER FDC single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fed condition Single tablets first, fasted Linagliptin/Metformin ER FDC single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fasted condition Single tablets first, fed Metformin ER single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fed condition FDC first, fasted Linagliptin Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fasted condition Single tablets first, fasted Linagliptin single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fasted condition
- Primary Outcome Measures
Name Time Method Maximum Measured Concentration of Linagliptin in Plasma (Cmax) 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration AUC 0-t (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Cmax of Metformin in Plasma 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration Cmax (maximum measured concentration of the Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72) 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration AUC 0-72 (area under concentration-time curve of the Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
- Secondary Outcome Measures
Name Time Method Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 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 Linagliptin.
The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.AUC0-inf of Metformin in Plasma 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 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.
The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.
Trial Locations
- Locations (1)
1288.9.1 Boehringer Ingelheim Investigational Site
🇩🇪Biberach, Germany