Bioequivalence Study of Two Formulations of 500 mg Metformin Extended Release Tablet

NACompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

December 31, 2009

Study Completion Date

January 31, 2010

Conditions
Metformin XR BE Study in Healthy Volunteers With Single and Multiple Dose
Interventions
DRUG

500 mg metformin hydrochloride extended release caplet (test drug)

In each of the two study periods (separated by a washout of one week) a single and multiple dose of test or reference product was administered.

DRUG

500 mg metformin hydrochloride prolonged release tablet (reference drug)

In each of the two study periods (separated by a washout of one week) a single and multiple dose of test or reference product was administered.

Trial Locations (1)

12430

PT Equilab International, Jakarta

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Dexa Medica Group

INDUSTRY

NCT01677260 - Bioequivalence Study of Two Formulations of 500 mg Metformin Extended Release Tablet | Biotech Hunter | Biotech Hunter