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

NCT05753371 | Completed

• 1 other identifier: 634/STD/PML/2021
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Use

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Geometric Mean Ratio

  The ratio between maximum concentration of test drug and reference drug after drug administration

  0-24 hours post dose

• Geometric Mean Ratio

  The ratio between area under curve from 0 to 24 hours of test drug and reference drug

  0-24 hours post dose

Secondary Outcomes (2)

• Pharmacokinetics Parameter

  0-24 hours post dose

• Pharmacokinetics Parameter

  0-24 hours post dose

Study Arms (2)

Glufor® 500 mg film-coated tablet

EXPERIMENTAL

Drug: Metformin Hydrochloride 500 MG

Glucophage® 500 mg film-coated tablet

ACTIVE COMPARATOR

Drug: Metformin Hydrochloride 500 MG

Interventions

Metformin Hydrochloride 500 MG DRUG

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.

Glucophage® 500 mg film-coated tablet; Glufor® 500 mg film-coated tablet

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• those who were pregnant and/or nursing women.
• those with history of contraindication or hypersensitivity to metformin or other antidiabetic agent or other ingredients in the study products or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction.
• those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease.
• those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities.
• those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day.
• those who had participated in any clinical study within 3 months prior to the study (\<90 days).
• those who had donated or lost 300 ml (or more) of blood within 3 months prior to the study.
• those who smoked more than 10 cigarettes a day
• those with a history of travelling to another city within the last 14 days
• those with a history of direct contact with a COVID-19 positive person in the subject's neighbourhood
• those with a history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days
• those who are positive to SARS CoV-2 antigen test
• those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential).
• those with a history of drug or alcohol abuse within 12 months prior to screening for this study.
• those who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access.

Sponsors & Collaborators

• PT. Pyridam Farma Tbk: lead
• PT Pharma Metric Labs: collaborator

Study Sites (1)

PT Pharma Metric Labs

Jakarta Pusat, DKI Jakarta, 10520, Indonesia

Location

Related Publications (2)

• Al Hawari S, AlGaai E, Yusuf A, Abdelgaleel A, Hammami MM. Bioequivalence study of two metformin formulations. Arzneimittelforschung. 2007;57(4):192-5. doi: 10.1055/s-0031-1296605.

  PMID: 17515289 BACKGROUND

• Batolar LS, Iqbal M, Monif T, Khuroo A, Sharma PL. Bioequivalence and pharmacokinetic comparison of 3 metformin extended/sustained release tablets in healthy Indian male volunteers. Arzneimittelforschung. 2012 Jan;62(1):22-6. doi: 10.1055/s-0031-1295428. Epub 2012 Jan 10.

  PMID: 22331759 BACKGROUND

Related Links

• Related Info
• Related Info

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Frans D Suyatna

  PT Pharma Metric Labs

  PRINCIPAL INVESTIGATOR

• I Gusti Putu Bagus Diana Virgo

  PT Pharma Metric Labs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: March 3, 2023
• Study Start: February 23, 2022
• Primary Completion: March 24, 2022
• Study Completion: March 31, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-02

Locations

ID (1)