NCT01160042

Bioequivalence Study of Metformin Hydrochloride Tablets 1000 mg Tablets of Dr. Reddy's Laboratories Limited Under Fasting Condition

A Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study of Metformin Hydrochloride 1000 mg Tablets (Dr. Reddy's Laboratories Ltd., Generics, India) to be Compared With Glucophage® (Metformin Hydrochloride) 1000 mg Tablets (Bristol-Myers Squibb, USA) in 52 + (2 Standby) Healthy, Adult, Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objectives of this study are: To compare the single dose bioavailability of Metformin Hydrochloride 1000 mg tablets (Dr. Reddy's Laboratories Ltd., Generics, India) with Glucophage (Metformin Hydrochloride) 1000 mg tablets (Bristol-Myers Squibb, USA) in 52 + (2 standby) healthy, adult, human subjects under fasting conditions. To monitor adverse events and to ensure the safety of subjects.

Detailed description

Open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,crossover bioequivalence study with at least 07 days of washout period between each drug administration under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Metformin	Metformin Tablets 1000 mg
DRUG	Glucophage	Glucophage 1000 mg tablets of Bristol-Myers Squibb

Timeline

• Start date: 2005-01-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2010-07-12
• Last updated: 2010-07-26

Locations

1 site across 1 country: India