Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg Under Fasting Condition

Fasting Clinical Trial

Official title: A Randomized, Open Label, Two-treatment, Two -Period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg of Ipca Laboratories Ltd, India and GLUCOPHAGE®XR (Metformin HCl Extended-release Tablets) 750 mg of Bristol-Myers Squibb Company, USA in Normal, Healthy, Adult, Human Subjects Under Fasting Condition

Status Completed

Clinical Trial Summary

The study was a randomized, open label, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in normal, healthy adult human subjects under fasting condition.

Clinical Trial Description

Objective of the study is to compare and evaluate the single-dose oral bioavailability of Metformin Hydrochloride Extended-Release Tablets USP 750 mg of Ipca Laboratories Ltd, India and GLUCOPHAGE®XR (Metformin HCl extended-release tablets) 750 mg of Bristol-Myers Squibb Company, USA in normal, healthy, adult, human subjects under fasting condition.

Total duration of the study was of 17 days from the day of admission of first period till the end of second period.

Upon entering into the study, subjects were housed in clinical facility of Veeda Clinical Research Pvt. Ltd. to ensure 10 hours overnight fasting before dosing and continued to be housed in the facility till 36.00 hours post-dose blood sample collection in each of the two periods.

A gap of 14 days was kept as wash out between each consecutive dosing period. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasting

• NCT number: NCT01831661
• Study type: Interventional
• Source: IPCA Laboratories Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: December 2012
• Completion date: February 2013