BioequivalencePhase 1NCT03458208
Bioequivalence Study of Metformin 1000 mg Tablets Immediate Release (IR) Versus Glucophage® 1000 mg Tablets IR In Healthy Subjects
A Phase 1 study testing Metformin and Glucophage® in people with Bioequivalence, run by Geropharm at 1 site in Russia.
Trial summary
Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage® Merck ) Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Metformin and Glucophage®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteRussia
- Study dates
- 14 Feb 2017to 2 Mar 2017
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent form.
- Healthy male and female subjects aged 18 to 45 years.
- Verified diagnosis is "healthy" according to data Standard clinical, laboratory and Instrumental methods of examination.
- Have a body mass index between 18,5 and 27 kg/m2.
- Females must have a negative pregnancy test.
- Subjects must use, with their partner, methods of highly effective contraception throughout the study and 30 days after the end of study.
Who cannot join
- History of serious allergic problems/events
- Medicinal intolerance.
- History of allergic reactions to memantine or investigator's product components
- Any acute and chronic diseases of the cardiovascular system, cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
- Acute infectious diseases in less than 4 weeks before the start of the study.
- Subjects who have taken medication 4 weeks preceding before the study.
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- Subjects who have taken any drugs known effects on hemodynamics or to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication (examples of inducers: barbiturates, omeprazole, etc.).
- Donation of plasma (450 mL or more) within 2 month prior to administration of the study medication.
- History of significant alcohol or drugs abuse or any indication of the regular use of more than 10 units of alcohol per week (1 Unit = 200 mL of wine or 500 mL of beer or 50 mL of alcohol 40%).
- Smokers.
- Participation in other clinical training is less than than for 3 months before the study.
- Lack of signed informed consent form.
- ECG or vital signs abnormalities (clinically significant).
- Positive testing for alcohol, drugs, pregnancy.
- Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours before the start of the study.
- Any diet, for example, vegetarian, for 2 weeks before taking the study medications.
- Women with preserved reproductive potential who have unprotected sexual intercourse with an unsterilized male partner within 30 days prior to taking the study medication.
- Heart rate below 60 or above 80 beats per minute.
- Systolic blood pressure less than 110 mm Hg or more than 139 mm Hg.
- Diastolic blood pressure less than 70 mm Hg or more than 89 mm Hg.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Four-way Crossover, Open-label, Single-dose, Bioequivalence Study of Metformin (LLC "GEROPHARM", Russia) 1000 mg Tablets Immediate Release (IR )Versus Glucophage® (Merck Sante S.A.S, France) 1000 mg Tablets IR in Normal Healthy Subjects Under Fasting and Fed Conditions
Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage® Merck )
Read the detailed description
Study to evaluate the bioequivalence of orally administered metformin preparations, immediate release tablets, 1 000 mg in normal healthy subjects under fasting and fed conditions
- Conditions
- Bioequivalence
- Being tested
- Metformin, Glucophage®
- Keywords
- AUC, Cmax, Pharmacokinetics, metformin, fed, fasting
- Medical subject headings
- Lecithin Cholesterol Acyltransferase Deficiency, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called fasting condition
First aIntervention Period:
Single administered dose of Metformin (1 000 mg tablet immediate release) in a fasting condition
Glucophage®Drug
Also called fasting condition
Second Intervention Period:
Single administered dose of Glucophage® (1 000 mg tablet immediate release) in a fasting condition
MetforminDrug
Also called fed condition
Third Intervention Period:
Single administered dose of Metformin (1 000 mg tablet immediate release) in a fed condition
Glucophage®Drug
Also called fed condition
Fourth Intervention Period:
Single administered dose of Metformin (1 000 mg tablet immediate release) in a fed condition
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | First aIntervention Period:
Single administered dose of Metformin (1 000 mg tablet immediate release) in a fasting condition
Third Intervention Period:
Single administered dose of Metformin (1 000 mg tablet immediate release) in a fed condition Receives: Drug: Metformin |
| Glucophage® | Active comparator | Second Intervention Period:
Single administered dose of Glucophage® ( 1 000 mg tablet immediate release) in a fasting condition
Fourth Intervention Period:
Single administered dose of Glucophage® ( 1 000 mg tablet immediate release) in a fed condition Receives: Drug: Glucophage® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Pharmacokinetics of metformin by Assessment of Observed Maximum Plasma Concentration (Cmax)
Measured: 0 hours (pre-dose), as well as at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 26 hours post-dose
AUC(0-t)
Pharmacokinetics of metformin by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
Measured: 0 hours (pre-dose), as well as at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 26 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 posted8 Mar 2018
- Study start14 Feb 2017
- Primary completion2 Mar 2017
- Study completion2 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- four-way crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geropharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sergey M Noscor, MD, Doctor of science, Principal investigator, Yarosslavl Clinical Hospital #3
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458208
- Sponsor's protocol ID
- BIOMET-IR
- Status last verified
- Jul 2018
- First submitted
- 26 Feb 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four-way Crossover, Open-label, Single-dose, Bioequivalence Study of Metformin (LLC "GEROPHARM", Russia) 1000 mg Tablets Immediate Release (IR )Versus Glucophage® (Merck Sante S.A.S, France) 1000 mg Tablets IR in Normal Healthy Subjects Under Fasting and Fed Conditions
- ClinicalTrials.gov ID
- NCT03458208
- Acronym / sponsor ID
- BIOMET-IR
- Conditions
- Bioequivalence
- Keywords
- AUC, Cmax, Pharmacokinetics, metformin, fed, fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GeropharmIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 2 Mar 2017 (actual)
- First posted
- 8 Mar 2018 (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.
Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage® Merck )
Detailed description
Study to evaluate the bioequivalence of orally administered metformin preparations, immediate release tablets, 1 000 mg in normal healthy subjects under fasting and fed conditions
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- four-way crossover
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminFirst aIntervention Period: Single administered dose of Metformin (1 000 mg tablet immediate release) in a fasting condition Third Intervention Period: Single administered dose of Metformin (1 000 mg tablet immediate release) in a fed condition |
| Glucophage® | Active comparator | Drug: Glucophage®Second Intervention Period: Single administered dose of Glucophage® ( 1 000 mg tablet immediate release) in a fasting condition Fourth Intervention Period: Single administered dose of Glucophage® ( 1 000 mg tablet immediate release) in a fed condition |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed informed consent form.
- Healthy male and female subjects aged 18 to 45 years.
- Verified diagnosis is "healthy" according to data Standard clinical, laboratory and Instrumental methods of examination.
- Have a body mass index between 18,5 and 27 kg/m2.
- Females must have a negative pregnancy test.
Key exclusion criteria (20 listed)
- History of serious allergic problems/events
- Medicinal intolerance.
- History of allergic reactions to memantine or investigator's product components
- Any acute and chronic diseases of the cardiovascular system, cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
- Acute infectious diseases in less than 4 weeks before the start of the study.
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 |
|---|---|---|
| MetforminAlso: fasting conditionFirst aIntervention Period: Single administered dose of Metformin (1 000 mg tablet immediate release) in a fasting condition | Drug | Metformin |
| Glucophage®Also: fasting conditionSecond Intervention Period: Single administered dose of Glucophage® (1 000 mg tablet immediate release) in a fasting condition | Drug | Glucophage® |
| MetforminAlso: fed conditionThird Intervention Period: Single administered dose of Metformin (1 000 mg tablet immediate release) in a fed condition | Drug | Metformin |
| Glucophage®Also: fed conditionFourth Intervention Period: Single administered dose of Metformin (1 000 mg tablet immediate release) in a fed condition | Drug | Glucophage® |
Primary outcome
Cmax
Time frame: 0 hours (pre-dose), as well as at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 26 hours post-dose
Pharmacokinetics of metformin by Assessment of Observed Maximum Plasma Concentration (Cmax)
AUC(0-t)
Time frame: 0 hours (pre-dose), as well as at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 26 hours post-dose
Pharmacokinetics of metformin by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
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 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Sergey M Noscor, MD, Doctor of science principal investigator
Yarosslavl Clinical Hospital #3
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metformin and Glucophage® in people with Bioequivalence, run by Geropharm at 1 site in Russia.
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 6 inclusion and 20 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 Jul 2018. 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 Russia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cmax (time frame: 0 hours (pre-dose), as well as at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, and 26 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?
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 Jul 2018.