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 combinations (FDC) tablets containing empagliflozin \& metformin XR and the single tablets of empagliflozin and metformin XR 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 dose combination (FDC) tablets vs 4 single tablets under fasted conditions

Interventions: intervention 1: 1 tablet Empagliflozin/2 tablets Metformin XR intervention 2: 10 mg Empagliflozin/1000 mg Metformin XR intervention 3: 1 tablet 10 mg Empagliflozin/3 tablets Metformin XR intervention 4: 2 tablets 5 mg Empagliflozin/750 Metformin XR intervention 5: 1 tablet Empagliflozin/2 tablets Metformin XR intervention 6: 10 mg Empagliflozin/1000 mg Metformin XR
Intervention descriptions: intervention 1: Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets intervention 2: Experimental: high dose Empagliflozin/Metformin XR, FDC tablet intervention 3: Active Comparator: 1 x Empagliflozin/3 x Metformin XR tablets intervention 4: Experimental:2 x low dose Empagliflozin/Metformin XR FDC tablets intervention 5: Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets intervention 6: Experimental: high dose Empagliflozin/Metformin XR, FDC tablet

Protocol document: