NCT05125575

Fed Bioequivalence Study of 2 Metformin 1000 mg Prolonged Release Tablets in 28 Healthy Male and Female Volunteers

Open, Comparative, Randomized, Crossover, Single Dose Bioequivalence Study of Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine) vs Glucophage® XR 1000 mg Prolonged Release Tablets in Healthy Subjects Under Fed Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Joint Stock Company "Farmak" · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study was designed to compare the bioavailability of the Test Product Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono Ltd, UK) in healthy male and female volunteers under fed conditions.

Detailed description

An Open, Comparative, Randomized, Crossover Clinical Trial to Evaluate the Bioequivalence of Single Doses of Test Product Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono Ltd, UK) in Healthy, Adult Male and Female Subjects Under Fed Conditions. During each period 21 blood samples were taken: prior to dosing (-1.0) and 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 10.0, 12.0, 16.0, 24.0, 32.0 and 36.0 hours after IMP administration.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine)	One tablet of the Test (T) product was administered orally with 240 mL of water.
DRUG	Glucophage® XR 1000 mg Prolonged Release Tablets	One tablet of the Reference (R) product was administered orally with 240 mL of water.

Timeline

• Start date: 2019-01-11
• Primary completion: 2019-01-19
• Completion: 2019-01-19
• First posted: 2021-11-18
• Last updated: 2021-11-18

Locations

1 site across 1 country: Czechia