Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 32
Healthy volunteers: yes

Brief summary:
The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed dose combination tablets compared to tablets administered together in healthy male and female volunteers under fed conditions.

Detailed description:

Arms:
arm 1: 12.5 mg Empagliflozin / 500mg metformin fixed dose combination arm 2: Empagliflozin and Metformin tablets

Interventions: intervention 1: Empagliflozin 2.5 mg intervention 2: Empagliflozin 10 mg intervention 3: Metformin 500 mg intervention 4: Empagliflozin/Metformin FDC
Intervention descriptions: intervention 1: Empagliflozin 2.5 mg tablet intervention 2: Empagliflozin 10 mg tablet intervention 3: Metformin 500 mg tablet intervention 4: 12.5 mg Empagliflozin / 500 mg Metformin

Protocol document: