Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/850 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy® 5 mg/850 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)

PHASE1CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

January 20, 2025

Primary Completion Date

February 28, 2025

Study Completion Date

February 28, 2025

Conditions
Diabetes Mellitus Type 2
Interventions
DRUG

Empagliflozin + Metformin hydrochloride 5 mg/850 mg combination film-coated tablets

1 tablet of Empagliflozin + Metformin hydrochloride 5 mg/850 mg combination film-coated tablet

DRUG

Synjardy® 5 mg/850 mg film-coated tablets

1 tablet of Empagliflozin+Metformin 5 mg/850 mg filmcoated tablets

Trial Locations (1)

150054

"State Budgetary Institution of Healthcare of Yaroslavl region Yaroslavl Regional Clinical Narcological Hospital", Yaroslavl

Sponsors
All Listed Sponsors
lead

Gedeon Richter Plc.

INDUSTRY