Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets
Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
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.