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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05753371

Enrollment

Registered

2023-03-03

Start date

2022-02-23

Completion date

2022-03-31

Last updated

2023-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Use

Keywords

Metformin hydrochloride 500 mg, Bioequivalence study, Pharmacokinetics, Indonesian healthy subject

Brief 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.

Interventions

DRUGMetformin 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 52 Years

Healthy volunteers

Yes

Inclusion criteria

The inclusion criterias were healthy male or female subjects who/with: * had read the subject information and signed informed consent documents * age range from 18 - 55 years * body mass index between 18 - 25 kg/m2 * had a normal electrocardiogram * had the blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg) * had the heart rate within normal range (60 - 100 bpm) * had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening.

Exclusion criteria

s The subjects'

Design outcomes

Primary

Measure	Time frame	Description
Geometric Mean Ratio	0-24 hours post dose	The ratio between maximum concentration of test drug and reference drug after drug administration

Secondary

Measure	Time frame	Description
Pharmacokinetics Parameter	0-24 hours post dose	Maximum plasma concentration (Cmax)

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026