Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 68
Healthy volunteers: yes

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:

Arms:
arm 1: Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fasted condition arm 2: single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fasted condition arm 3: Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fed condition arm 4: single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fed condition

Interventions: intervention 1: Linagliptin/Metformin ER FDC intervention 2: Linagliptin intervention 3: Metformin ER
Intervention descriptions: intervention 1: 1x Linagliptin/Metformin FDC tablet intervention 2: 1x Linagliptin tablet intervention 3: 2x Metformin ER tablets

Protocol document: