Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 50
Healthy volunteers: yes

Brief summary:
The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin, linagliptin \& metformin extended release (XR) and the single tablets of empagliflozin, linagliptin and metformin XR administered simultaneously.

Detailed description:

Arms:
arm 1: 1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions arm 2: 1 fixed dose combination (FDC) tablet vs. 4 single tablets under fasted conditions arm 3: 1 fixed dose combination (FDC) tablet vs. 4 single tablets under fed conditions

Interventions: intervention 1: High dose FDC Empagliflozin/Linagliptin/Metformin XR, fed intervention 2: 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR intervention 3: High dose FDC Empagliflozin/Linagliptin/Metformin XR, fasted intervention 4: 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR intervention 5: Low dose FDC Empagliflozin/Linagliptin/Metformin XR, fed intervention 6: 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR
Intervention descriptions: intervention 1: High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet intervention 2: 1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets intervention 3: High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet intervention 4: 1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets intervention 5: Low dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet intervention 6: 1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets

Protocol document: