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

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 )

Study Overview

• Status: Completed
• Conditions: Bioequivalence
• Intervention / Treatment: Drug: Metformin; Drug: Metformin; Drug: Glucophage®; Drug: Glucophage®

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Yaroslavl, Russian Federation, 150007
    • Yarosslavl Clinical Hospital #3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; First aIntervention Period: Single administered dose of Metformin (1 000 mg tablet immediate release) in a fasting condition; Other Names: fasting condition; Drug: Metformin; Third Intervention Period: Single administered dose of Metformin (1 000 mg tablet immediate release) in a fed condition; Other Names: fed condition
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®; Second Intervention Period: Single administered dose of Glucophage® (1 000 mg tablet immediate release) in a fasting condition; Other Names: fasting condition; Drug: Glucophage®; Fourth Intervention Period: Single administered dose of Metformin (1 000 mg tablet immediate release) in a fed condition; Other Names: fed condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Pharmacokinetics of metformin by Assessment of Observed Maximum Plasma Concentration (Cmax)	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))	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

Collaborators and Investigators

• Sponsor: Geropharm
• Investigators: Principal Investigator: Sergey M Noscor, MD, Doctor of science, Yarosslavl Clinical Hospital #3

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2017
• Primary Completion (Actual): March 2, 2017
• Study Completion (Actual): March 2, 2017

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Pharmacokinetics; metformin; fasting; fed; AUC; Cmax
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: BIOMET-IR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No