Bioequivalence Study of 4 mg Glimepiride Tablet

NACompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions
Glimepiride BE Study in Healthy Volunteers Under Fasting Condition
Interventions
DRUG

Group I (Test) : Glimepiride 4 mg tablet of PT Dexa Medica

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

DRUG

Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi Aventis

In each of the two study periods (separated by a washout of one week) a single 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

NCT01677247 - Bioequivalence Study of 4 mg Glimepiride Tablet | Biotech Hunter | Biotech Hunter