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

NCT03458208 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-07-03

No results posted yet for this study

Summary

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

Conditions

  • Bioequivalence

Interventions

DRUG

Metformin

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

DRUG

Glucophage®

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

DRUG

Metformin

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

DRUG

Glucophage®

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

Sponsors & Collaborators

  • Geropharm

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-14
Primary Completion
2017-03-02
Completion
2017-03-02

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03458208 on ClinicalTrials.gov