Clinical trial NCT05753371: Bioequivalence Study of Metformin Hydrochloride 500 mg Film-Coated Tablets in Indonesia Healthy Subject
Official title: Bioequivalence Study of Metformin Hydrochloride 500 mg Film-Coated Tablets in Indonesia Healthy Subject
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Use
Keywords: Metformin hydrochloride 500 mg
Bioequivalence study
Pharmacokinetics
Indonesian healthy subject
Lead sponsor: PT. Pyridam Farma Tbk
Sponsor class: INDUSTRY
Collaborators: name: PT Pharma Metric Labs
First posted: 2023-03-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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 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.

Primary outcomes:
measure: Geometric Mean Ratio
timeFrame: 0-24 hours post dose
measure: Geometric Mean Ratio
timeFrame: 0-24 hours post dose
Secondary outcomes:
measure: Pharmacokinetics Parameter
timeFrame: 0-24 hours post dose
measure: Pharmacokinetics Parameter
timeFrame: 0-24 hours post dose
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: PT Pharma Metric Labs
state: DKI Jakarta
Study officials:
affiliation: PT Pharma Metric Labs
name: Frans D Suyatna
role: PRINCIPAL_INVESTIGATOR
affiliation: PT Pharma Metric Labs
name: I Gusti Putu Bagus Diana Virgo
role: STUDY_DIRECTOR
References:
citation: 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.
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.