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

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

Detailed description:

Arms:
arm 1: 3 single tablets under fed conditions arm 2: 2 FDC tablets under fasted conditions arm 3: 4 single tablets under fasted conditions arm 4: 1 fixed dose combination(FDC) tablet under fasted conditions arm 5: 3 single tablets under fasted conditions arm 6: 1 FDC tablet under fed conditions

Interventions: intervention 1: 2x500 mg Metformin (Glumetza) intervention 2: 5 mg Linagliptin/1000 mg Metformin FDC intervention 3: 5 mg Linagliptin (Tradjenta) intervention 4: 5 mg Linagliptin (Tradjenta) intervention 5: 3x500 mg Metformin (Glumetza) intervention 6: 5 mg Linagliptin (Tradjenta) intervention 7: 2 x 500 mg Metformin (Glumetza) intervention 8: 5 mg Linagliptin/1000mg Metformin FDC intervention 9: 2 x 2.5 mg Linagliptin/750 mg Metformin FDC
Intervention descriptions: intervention 1: 2 tablets intervention 2: FDC tablet intervention 3: 1 tablet intervention 4: 1 tablet intervention 5: 3 tablets intervention 6: 1 tablet intervention 7: 2 tablets intervention 8: FDC Tablet intervention 9: 2 FDC tablets

Protocol document: