Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 25
Healthy volunteers: yes

Brief summary:
Bioequivalence of two 12.5 mg empagliflozin/500 mg metformin fixed dose combination tablets compared to the free combination of empagliflozin 25 mg and metformin 1000 mg in healthy male and female volunteers under fed conditions

Detailed description:

Arms:
arm 1: fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin, oral with 200 mL of water uder fed conditions arm 2: free combination of 1 tablet of 25 mg Empagliflozin and 1 tablet of 1000 mg of Metformin, oral with 200 mL of water under fed conditions

Interventions: intervention 1: Empagliflozin intervention 2: Metformin intervention 3: Empagliflozin intervention 4: Metformin
Intervention descriptions: intervention 1: Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin intervention 2: Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin intervention 3: Reference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin intervention 4: Reference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin

Protocol document: