Fasting Bioequivalence Study of 2 Metformin 500 mg Prolonged Release Tablets in 44 Healthy Male and Female Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

May 21, 2021

Primary Completion Date

May 29, 2021

Study Completion Date

May 29, 2021

Conditions
Pharmacokinetics
Interventions
DRUG

Metformin 500mg prolonged release tablets (JSC Farmak, Ukraine)

One tablet of the Test product was administered orally with 240 mL of water.

DRUG

Glucophage® XR 500 mg prolonged release tablets (Merck Serono Ltd, UK)

One tablet of Reference (R) 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