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

Pharmacokinetics Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05123781
Study type Interventional
Source Joint Stock Company "Farmak"
Contact
Status Completed
Phase Phase 1
Start date April 3, 2019
Completion date April 17, 2019
View Details
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