Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief summary:
The primary objective of this trial is to establish bioequivalence of two fixed dose combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin \[Test 1\] and low dose empagliflozin/500 mg metformin \[Test 2\]) and of the single tablets (medium dose empagliflozin tablets + Glucophage® 500 mg tablet \[Reference 1\] and low dose empagliflozin tablet + Glucophage® 500 mg tablet \[Reference 2\]) when administered together after a high fat, high caloric meal.

The assessment of safety and tolerability will be an additional objective of this trial.

Detailed description:

Arms:
arm 1: fix dose combination tablet after intake of a high fat, high caloric meal arm 2: single tablets after intake of a high fat, high caloric meal arm 3: fix dose combination tablet after intake of a high fat, high caloric meal arm 4: single tablets after intake of a high fat, high caloric meal

Interventions: intervention 1: empagliflozin intervention 2: metformin (Glucophage®) intervention 3: metformin (Glucophage®) intervention 4: empagliflozin intervention 5: empagliflozin and metformin intervention 6: empagliflozin and metformin
Intervention descriptions: intervention 1: single tablet empagliflozin intervention 2: single tablet metformin intervention 3: single tablet metformin intervention 4: single tablet empagliflozin intervention 5: FDC tablet empagliflozin and metformin intervention 6: FDC tablet empagliflozin and metformin

Protocol document: