Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 48
Healthy volunteers: yes

Brief summary:
Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets empagliflozin and metformin under fed conditions (Part II).

Detailed description:

Arms:
arm 1: fixed-dose-combination tablet, oral with 240 ml water under fasted conditions arm 2: fixed-dose-combination tablet, oral with 240 ml water under fed conditions arm 3: tablets, oral with 240 ml water under fasted conditions arm 4: tablets, oral with 240 ml water under fed conditions arm 5: fixed-dose-combination tablet, oral with 240 ml water under fed conditions arm 6: tablets, oral with 240 ml water under fed conditions

Interventions: intervention 1: Empagliflozin intervention 2: Metformin intervention 3: Empagliflozin intervention 4: Empagliflozin/Metformin intervention 5: Metformin intervention 6: Empagliflozin/Metformin intervention 7: Empagliflozin intervention 8: Metformin intervention 9: Empagliflozin/Metformin
Intervention descriptions: intervention 1: medium dose oral administration intervention 2: oral administration intervention 3: low dose of Empagliflozin oral administration intervention 4: low dose of Empagliflozin intervention 5: oral administration intervention 6: medium dose of Empagliflozin oral administration intervention 7: medium dose oral administration intervention 8: oral administration intervention 9: medium dose of Empagliflozin oral administration

Protocol document: