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

Interventions: intervention 1: Linagliptin intervention 2: Metformin intervention 3: Linagliptin/Metformin FDC
Intervention descriptions: intervention 1: Linagliptin intervention 2: Metformin intervention 3: Linagliptin/Metformin FDC

Protocol document: