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

NCT03458208 | Completed Phase 1 DMC

• 1 other identifier: BIOMET-IR
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage® Merck )

Conditions

Bioequivalence

Keywords

AUC; Cmax; Pharmacokinetics; metformin; fed; fasting

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Drug: Glucophage®

Interventions

Metformin DRUG

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

Also known as: fasting condition

Metformin

Glucophage® DRUG

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

Also known as: fasting condition

Glucophage®

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Geropharm: lead

Study Sites (1)

Yarosslavl Clinical Hospital #3

Yaroslavl, 150007, Russia

Location

MeSH Terms

Conditions

Lecithin Cholesterol Acyltransferase Deficiency; Fasting

Interventions

Metformin

Condition Hierarchy (Ancestors)

Hypoalphalipoproteinemias; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Sergey M Noscor, MD, Doctor of science

  Yarosslavl Clinical Hospital #3

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: four-way crossover

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 8, 2018
• Study Start: February 14, 2017
• Primary Completion: March 2, 2017
• Study Completion: March 2, 2017
• Last Updated: July 3, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)