A Phase 1 interventional study of Metformine and Glucophage® Long in Bioequivalence, sponsored by Geropharm. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-03.
Sponsored by Geropharm · Phase 1, Interventional, and Basic science
Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage® Long Merck )
Study to evaluate the bioequivalence of orally administered metformin preparations, Extended release tablets, 750 mg in normal healthy subjects under fasting and fed conditions
392 studies on the registry are indexed under Fasting; 63 are open to participants now.
This study's enrollment of 28 is below the median of 45 across 311 interventional studies indexed under Fasting.
Browse Fasting studies →Geropharm is the lead sponsor of 23 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
First aIntervention Period: Single administered dose of Metformin (750 mg tablet extended-release in a fasting condition Third Intervention Period: Single administered dose of Metformin (750 mg tablet extended-release) in a fed condition
Drug: Metformine · Drug: Metformin
Second Intervention Period: Single administered dose of Glucophage® ( 750 mg tablet extended-release) in a fasting condition Fourth Intervention Period: Single administered dose of Glucophage® ( 750 mg tablet extended-release) in a fed condition
Drug: Glucophage® Long
First aIntervention Period: Single administered dose of Metformin (750 mg tablet extended-release) in a fasting condition
Also known as: fasting condition
Second Intervention Period: Single administered dose of Glucophage® (750 mg tablet extended-release) in a fasting condition
Also known as: fasting condition
Third Intervention Period: Single administered dose of Metformin (750 mg tablet extended-release) in a fed condition
Also known as: fed condition
Fourth Intervention Period: Single administered dose of Metformin (750 mg tablet extended-release) in a fed condition
Also known as: fed condition
Cmax
Pharmacokinetics of metformin by Assessment of Observed Maximum Plasma Concentration (Cmax)
Time frame: 0 hours (pre-dose), as well as at 0.5, 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0, 12.0, 16.0, 20.0, 24.0, 30.0 and 36 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))
Time frame: 0 hours (pre-dose), as well as at 0.5, 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0, 12.0, 16.0, 20.0, 24.0, 30.0 and 36 hours post-dose
Plan to share: No
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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Metformin