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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

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

Keywords

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

Who can participate

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

Inclusion criteria

  • 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.

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 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.
04

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

05

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

06

Study locations

1 site
  • Yarosslavl Clinical Hospital #3
    Yaroslavl, 150007, Russian Federation
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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 ↗

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