NCT01831661

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: IPCA Laboratories Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Fasting

Interventions

Type	Name	Description
DRUG	Metformin Hydrochloride Extended-Release Tablets USP 750 mg	Metformin Hydrochloride Extended-Release Tablets 750 mg once a day
DRUG	GLUCOPHAGE®XR	GLUCOPHAGE®XR 750 mg once a day

Timeline

• Start date: 2012-12-01
• Primary completion: 2012-12-01
• Completion: 2013-02-01
• First posted: 2013-04-15
• Last updated: 2013-04-15

Locations

1 site across 1 country: India