NCT03452306

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

Four-way Crossover, Open-label, Single-dose, Bioequivalence Study of Metformin (LLC "GEROPHARM", Russia) 750 mg Tablets Extended Release Versus Glucophage® Long (Merck Santé S.A.S, France) 750 mg Tablets Extended Release in Normal Healthy Subjects Under Fasting and Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (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® Long Merck )

Detailed description

Study to evaluate the bioequivalence of orally administered metformin preparations, Extended release tablets, 750 mg in normal healthy subjects under fasting and fed conditions

Conditions

• Bioequivalence

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-06-15
• Primary completion: 2017-07-22
• Completion: 2017-07-22
• First posted: 2018-03-02
• Last updated: 2018-07-03

Locations

1 site across 1 country: Russia