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Bioequivalence Study of Metformin Hydrochloride 500 mg Film-Coated Tablets in Indonesia Healthy Subject

Drug Use Clinical Trial

Official title:
Bioequivalence Study of Metformin Hydrochloride 500 mg Film-Coated Tablets in Indonesia Healthy Subject

Clinical Trial Summary

The objective of this present study was to investigate whether Glufor® 500 (metformin hydrochloride 500 mg) film-coated tablets manufactured by PT. Pyridam Farma Tbk is bioequivalent to its reference product, Glucophage® 500 mg film-coated tablets manufactured by PT. Merck Tbk, Indonesia under licensed Merck Sante SAS, France.

Clinical Trial Description

Twenty-four subjects were given a single dose of 500 mg Metformin film-coated tablet of either formulation (test or reference) with 240 mL of a 20% glucose solution in water. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05753371
Study type Interventional
Source PT. Pyridam Farma Tbk
Contact
Status Completed
Phase N/A
Start date February 23, 2022
Completion date March 31, 2022
View Details
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