NCT05753371

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: PT. Pyridam Farma Tbk · Industry
• Sex: All
• Age: 18 Years – 52 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Drug Use

Interventions

Type	Name	Description
DRUG	Metformin Hydrochloride 500 MG	Metformin is an antihyperglycemic drug used in the management of type-2 diabetes. Metformin hydrochloride improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Timeline

• Start date: 2022-02-23
• Primary completion: 2022-03-24
• Completion: 2022-03-31
• First posted: 2023-03-03
• Last updated: 2023-03-03

Locations

1 site across 1 country: Indonesia