NCT03458208

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Geropharm · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

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

Conditions

• Bioequivalence

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-02-14
• Primary completion: 2017-03-02
• Completion: 2017-03-02
• First posted: 2018-03-08
• Last updated: 2018-07-03

Locations

1 site across 1 country: Russia