Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 74
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.

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

Protocol document: