A Study in Healthy Humans to Assess the Relative Bioavailability of One Fixed-dose Combination Tablet Empagliflozin/Metformin Versus Jardiance® Tablet and Glifage® Tablet Administered Together (InPedILD®)

NCT05083949 PHASE1 COMPLETED Results posted

This trial is to establish bioequivalence of the fixed dose combination (FDC) tablets (containing 12.5 mg empagliflozin/850 mg metformin) (Test, T) compared with the single tablets (10 mg empagliflozin and Glifage® 850 mg tablets) (Reference, R).

Details

Lead sponsor	Boehringer Ingelheim
Phase	PHASE1
Status	COMPLETED
Enrolment	32
Start date	Fri Jul 23 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Sep 09 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Healthy

Interventions

• FDC 12.5mg empagliflozin/850mg metformin
• Empagliflozin
• Glifage®

Countries

Brazil