Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 72
Healthy volunteers: yes

Brief summary:
The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing empagliflozin \& metformin and the single tablets of empagliflozin and metformin when administered singularly.

Detailed description:

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

Interventions: intervention 1: Empagliflozin/Metformin XR, FDC intervention 2: Empagliflozin/Metformin XR FDC intervention 3: 25 mg Empagliflozin/1000 mg Metformin XR, FDC intervention 4: 1 tablet Empagliflozin/2 tablets Metformin XR intervention 5: 1 tablet Empagliflozin/3 tablets Metformin XR intervention 6: 1 tablet Empagliflozin/2 tablets Metformin XR
Intervention descriptions: intervention 1: Experimental: high dose empagliflozin/metformin XR, FDC tablet intervention 2: Experimental: low dose empagliflozin/metformin XR, FDC tablet intervention 3: Experimental, high dose Empagliflozin/Metformin XR,FDC Tablet intervention 4: Active Comparator: 1x empagliflozin/2x metformin XR tablets intervention 5: Active Comparator: 1x empagliflozin/3x metformin XR tablets intervention 6: Active Comparator: 1x empagliflozin/2x metformin XR tablets

Protocol document: