Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 12.5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 12.5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany)

PHASE1CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

May 11, 2025

Primary Completion Date

May 21, 2025

Study Completion Date

May 21, 2025

Conditions
Diabetes Mellitus Type 2
Interventions
DRUG

Empagliflozin + Metformin hydrochloride 12.5 mg/1000 mg combination film-coated tablets

1 tablet of Empagliflozin + Metformin hydrochloride 12.5 mg/1000 mg combination film-coated table

DRUG

Synjardy 12.5 mg/1000 mg film-coated tablets

1 tablet of Empagliflozin+Metformin 12.5 mg/1000 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

NCT06823856 - Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 12.5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hungary) Versus Synjardy 12.5 mg/1000 mg Film-coated Tablets (Boehringer Ingelheim International GmbH, Germany) | Biotech Hunter | Biotech Hunter