NCT05124717

Fed Bioequivalence Study of 2 Metformin 500 mg Prolongued Release Tablets in 28 Healthy Male and Female Volunteers

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

The objective of the study is to compare the bioavailability of the Test and Reference products both containing Metformin 500 mg prolonged release tablets (MFM) in healthy male and female volunteers under fed conditions and to assess the bioequivalence of these products based on confidence acceptance intervals of 80.00% to 125.00% for AUC(o-t)and Cmax of MFM as primary endpoints.

Detailed description

An Open, Comparative, Randomized, Crossover Clinical Trial to Evaluate the Bioequivalence of Single Doses of Test Product Metformin, prolonged-release tablets 500 mg (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 Fed Conditions Single oral dose of Glucophage® XR 500 mg prolonged release tablets of Reference product or Metformin, prolonged-release tablets 500 mg of Test product will be administered to volunteers under fed conditions in the morning of Day 1 of each Study Period. Pharmacokinetic parameters of MFM were calculated from plasma concentrations determined by validated HPLC/MS/MS method. Pharmacokinetic parameters of the Test and Reference tablets were compared. During each period 21 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 in each study period. The study consists of two study periods with a washout period of at least 7 days between doses. Adverse events and clinically significant deviations from laboratory tests, physical examinations and vital signs were reported for the evaluation of safety.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Metformin, prolonged-release tablets 500 mg (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 the Reference product was administered orallyn with 240 mL of water.

Timeline

• Start date: 2019-06-25
• Primary completion: 2019-07-03
• Completion: 2019-07-03
• First posted: 2021-11-18
• Last updated: 2021-11-18

Locations

1 site across 1 country: Czechia