NCT05124730

Fasting Bioequivalence Study of 2 Metformin 500 mg Prolonged Release Tablets in 44 Healthy Male and Female Volunteers

Open, Comparative, Randomized, Crossover, Single Dose Bioequivalence Study of Metformin 500 mg Prolonged Release Tablets (JSC Farmak, Ukraine) vs Glucophage® XR 500 mg Prolonged Release Tablets in Healthy Subjects Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (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 500mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 500 mg Prolonged Release Tablets (Merck Serono Ltd, UK) in healthy male and female volunteers under fasting conditions.

Detailed description

An Open, Comparative, Randomized, Crossover Clinical Trial to Evaluate the Bioequivalence of Single Doses of Test Product Metformin 500mg Prolonged Release Tablets (JSC Farmak, Ukraine) and Reference Product Glucophage® XR 500 mg Prolonged Release Tablets (Merck Serono Ltd, UK) in Healthy, Adult Male and Female Subjects under Fasting 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 Investigational Medicinal Product (IMP) administration.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Metformin 500mg prolonged release tablets (JSC Farmak, Ukraine)	One tablet of the Test product was administered orally with 240 mL of water.
DRUG	Glucophage® XR 500 mg prolonged release tablets (Merck Serono Ltd, UK)	One tablet of Reference (R) Product was administered orally with 240 mL of water.

Timeline

• Start date: 2021-05-21
• Primary completion: 2021-05-29
• Completion: 2021-05-29
• First posted: 2021-11-18
• Last updated: 2021-11-18

Locations

1 site across 1 country: Czechia