Drug UseNCT05753371
Bioequivalence Study of Metformin Hydrochloride 500 mg Film-Coated Tablets in Indonesia Healthy Subject
A study testing Metformin Hydrochloride 500 MG in people with Drug Use, run by PT. Pyridam Farma Tbk at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 52 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Use
- What is being tested?
- Metformin Hydrochloride 500 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 23 Feb 2022to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Metformin Hydrochloride 500 MG
- Keywords
- Metformin hydrochloride 500 mg, Bioequivalence study, Pharmacokinetics, Indonesian healthy subject
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin Hydrochloride 500 MGDrug
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 group | Role | What they receive |
|---|---|---|
| Glufor® 500 mg film-coated tablet | Experimental | Not described Receives: Drug: Metformin Hydrochloride 500 MG |
| Glucophage® 500 mg film-coated tablet | Active comparator | Not described Receives: Drug: Metformin Hydrochloride 500 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Ratio
The ratio between maximum concentration of test drug and reference drug after drug administration
Measured: 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
Measured: 0-24 hours post dose
Secondary outcomes (2)
Pharmacokinetics Parameter
Maximum plasma concentration (Cmax)
Measured: 0-24 hours post dose
Pharmacokinetics Parameter
Area Under Curve from 0 to 24 hours (AUCt)
Measured: 0-24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start23 Feb 2022
- Primary completion24 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Drug UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT. Pyridam Farma Tbk
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PT Pharma Metric Labs
- Responsible party
- Sponsor
- Investigators
- Frans D Suyatna, Principal investigator, PT Pharma Metric LabsI Gusti Putu Bagus Diana Virgo, Study director, PT Pharma Metric Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753371
- Sponsor's protocol ID
- 634/STD/PML/2021
- Status last verified
- Feb 2023
- First submitted
- 12 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 17515289Batolar 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.
PubMed 22331759
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Metformin Hydrochloride 500 mg Film-Coated Tablets in Indonesia Healthy Subject
- ClinicalTrials.gov ID
- NCT05753371
- Acronym / sponsor ID
- 634/STD/PML/2021
- Conditions
- Drug Use
- Keywords
- Metformin hydrochloride 500 mg, Bioequivalence study, Pharmacokinetics, Indonesian healthy subject
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PT. Pyridam Farma TbkIndustry (pharma, biotech, devices)
- Collaborators
- PT Pharma Metric Labs
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin Hydrochloride 500 MGMetformin 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. | Drug | Glucophage® 500 mg film-coated tablet, Glufor® 500 mg film-coated tablet |
Primary outcome
Geometric Mean Ratio
Time frame: 0-24 hours post dose
The ratio between maximum concentration of test drug and reference drug after drug administration
Geometric Mean Ratio
Time frame: 0-24 hours post dose
The ratio between area under curve from 0 to 24 hours of test drug and reference drug
2 secondary outcomes
Pharmacokinetics Parameter
Time frame: 0-24 hours post dose
Pharmacokinetics Parameter
Time frame: 0-24 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Background: PubMed 17515289Al 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.
- Background: PubMed 22331759Batolar 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frans D Suyatna principal investigator
PT Pharma Metric Labs
I Gusti Putu Bagus Diana Virgo study director
PT Pharma Metric Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin Hydrochloride 500 MG in people with Drug Use, run by PT. Pyridam Farma Tbk at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Ratio (time frame: 0-24 hours post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05753371, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.