Fasting Bioequivalence Study of 2 Metformin 1000 mg Prolonged Release Tablets in 28 Healthy Male and Female Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

April 3, 2019

Primary Completion Date

April 17, 2019

Study Completion Date

April 17, 2019

Conditions
Pharmacokinetics
Interventions
DRUG

Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine)

One tablet of the test product was administered orally with 240 ml of water

DRUG

Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono Ltd, UK)

One tablet of the Reference product was administered orally with 240 ml of water

Trial Locations (1)

10200

QUINTA-ANALYTICA s.r.o., Prague

All Listed Sponsors
lead

"Joint Stock Company Farmak"

INDUSTRY

NCT05123781 - Fasting Bioequivalence Study of 2 Metformin 1000 mg Prolonged Release Tablets in 28 Healthy Male and Female Volunteers | Biotech Hunter | Biotech Hunter