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 Details — Status: Completed

Administrative data

• NCT number: NCT05753371
• Other study ID #: 634/STD/PML/2021
• Status: Completed
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: March 31, 2022

Study information

• Verified date: February 2023
• Source: PT. Pyridam Farma Tbk
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 31, 2022
• Est. primary completion date: March 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 52 Years

Eligibility

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 criterias

The subjects' exclusion criterias for the study were:

• 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.

Related Conditions & MeSH terms

• Drug Use

Intervention

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.

Locations

Country	Name	City	State
Indonesia	PT Pharma Metric Labs	Jakarta Pusat	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
PT. Pyridam Farma Tbk	PT Pharma Metric Labs

Country where clinical trial is conducted

Indonesia, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Ratio	The ratio between maximum concentration of test drug and reference drug after drug administration	0-24 hours post dose
Primary	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	Pharmacokinetics Parameter	Maximum plasma concentration (Cmax)	0-24 hours post dose
Secondary	Pharmacokinetics Parameter	Area Under Curve from 0 to 24 hours (AUCt)	0-24 hours post dose

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