Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 18
Healthy volunteers: yes

Brief summary:
Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting conditions.

Detailed description:

Arms:
arm 1: high dose of empagliflozin after overnight fasting for at least 10 h arm 2: high dose of empagliflozin after a standardised high fat breakfast arm 3: low dose empagliflozin after overnight fasting for at least 10 h

Interventions: intervention 1: Empagliflozin intervention 2: Empagliflozin intervention 3: Empagliflozin
Intervention descriptions: intervention 1: high dose of empagliflozin after overnight fasting for at least 10 h intervention 2: low dose empagliflozin after overnight fasting for at least 10 h intervention 3: high dose of empagliflozin after a standardised high fat breakfast

Protocol document: