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CompletedNCT03458208Updated Jul 3, 2018

Bioequivalence Study of Metformin 1000 mg Tablets Immediate Release (IR) Versus Glucophage® 1000 mg Tablets IR In Healthy Subjects

A Phase 1 interventional study of Metformin and Glucophage® 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

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Feb 2017, registered Feb 2018).
Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Bioequivalence

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Keywords

  • AUC
  • Cmax
  • Pharmacokinetics
  • metformin
  • fed
  • fasting
03

In context

Fasting

392 studies on the registry are indexed under Fasting; 63 are open to participants now.

This study's enrollment of 18 is below the median of 45 across 311 interventional studies indexed under Fasting.

Browse Fasting studies →

Lead sponsor

Geropharm is the lead sponsor of 23 studies on the registry; none are open to participants now.

Browse Geropharm studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Signed 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 between 18,5 and 27 kg/m2.
  • Females must have a negative pregnancy test.
  • Subjects must use, with their partner, methods of highly effective throughout the study and 30 days after the end of study.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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 form.
  • or vital signs abnormalities ().
  • 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 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.
Terms in these criteria, in plain language(6)

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.

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.

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.

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.

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.

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.

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.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Metformin

    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

    Drug: Metformin

  • Active comparator
    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

    Drug: Glucophage®

Interventions

  • DrugMetformin

    First aIntervention Period: Single administered dose of Metformin (1 000 mg tablet immediate release) in a fasting condition

    Also known as: fasting condition

  • DrugGlucophage®

    Second Intervention Period: Single administered dose of Glucophage® (1 000 mg tablet immediate release) in a fasting condition

    Also known as: fasting condition

  • DrugMetformin

    Third Intervention Period: Single administered dose of Metformin (1 000 mg tablet immediate release) in a fed condition

    Also known as: fed condition

  • DrugGlucophage®

    Fourth Intervention Period: Single administered dose of Metformin (1 000 mg tablet immediate release) in a fed condition

    Also known as: fed condition

06

What researchers measure

Primary outcomes

  1. 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, 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

  2. 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, 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

07

Study locations

1 site
  • Yarosslavl Clinical Hospital #3
    Yaroslavl, 150007, Russian Federation
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2017 to primary completion in Mar 2017, 0 months.

Of 18 phase 1 interventional studies under Fasting, half reached primary completion within 1 month of starting (the median), counting those still running; a quarter within 0 and three quarters within 3. This study's 0 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2018
First posted
Mar 8, 2018
StartActual
Feb 14, 2017
Primary completionActual
Mar 2, 2017
CompletionActual
Mar 2, 2017
Last update
Jul 3, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03458208
Lead sponsor
Geropharm
Responsible party
Sponsor
First posted
Mar 8, 2018
Start date
Feb 14, 2017
Primary completion
Mar 2, 2017
Completion
Mar 2, 2017
Last update
Jul 3, 2018

Study contacts

Sergey M Noscor, MD, Doctor of science
principal investigator · Yarosslavl Clinical Hospital #3

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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Discussion

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