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Bioequivalence Study of Metformin 750 mg Tablets XR Versus Glucophage® Long 750 mg Tablets XR In Normal Healthy Subjects Under Fasting and Fed Conditions

NCT03452306 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-07-03

No results posted yet for this study

Summary

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

Conditions

  • Bioequivalence

Interventions

DRUG

Metformine

First aIntervention Period: Single administered dose of Metformin (750 mg tablet extended-release) in a fasting condition

DRUG

Glucophage® Long

Second Intervention Period: Single administered dose of Glucophage® (750 mg tablet extended-release) in a fasting condition

DRUG

Metformin

Third Intervention Period: Single administered dose of Metformin (750 mg tablet extended-release) in a fed condition

DRUG

Glucophage® Long

Fourth Intervention Period: Single administered dose of Metformin (750 mg tablet extended-release) in a fed condition

Sponsors & Collaborators

  • Geropharm

    lead INDUSTRY

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
2017-06-15
Primary Completion
2017-07-22
Completion
2017-07-22

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 NCT03452306 on ClinicalTrials.gov