NCT05123781

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

An Open, Comparative, Randomized, Crossover, Bioequivalence Study of Metformin, Prolonged-release Tablets 500 mg (JSC Farmak, Ukraine) vs Glucophage® XR in Healthy, Adult Male and Female Subjects Under Fasting 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

The primary objective was to compare the rate and extent of absorption of Metformin XR after administration of a 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), administered as a single dose in healthy subjects under fasting conditions. The adverse events, physical examinations and vital signs were reported for the evaluation of safety.

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 Fasting Conditions. Single oral dose of Test of Reference product of Metformin 1000 mg Prolonged Release Tablets was administered to volunteers under fasting conditions in the morning of Day 1 of each Study Period. The study consists of two study periods with a washout period of at least 7 days between doses. During each study 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 product was administered orally with 240 ml of water
DRUG	Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono Ltd, UK)	One tablet of the Reference product was administered orally with 240 ml of water

Timeline

• Start date: 2019-04-03
• Primary completion: 2019-04-17
• Completion: 2019-04-17
• First posted: 2021-11-17
• Last updated: 2021-11-17

Locations

1 site across 1 country: Czechia