Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 30
Healthy volunteers: yes

Brief summary:
The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing empagliflozin and metformin extended release compared to the free combination of empagliflozin and metformin extended release under fed conditions.

Detailed description:

Arms:
arm 1: Single dose empagliflozin/metformin arm 2: single doses empagliflozin and metformin

Interventions: intervention 1: metformin intervention 2: empagliflozin/metformin intervention 3: empagliflozin
Intervention descriptions: intervention 1: single dose of metformin given as tablets intervention 2: Single dose empagliflozin/metformin given as fixed-dose combination tablet intervention 3: single dose of empagliflozin given as tablet

Protocol document: