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

2014-08-27 03:12:18 | BioPortfolio

Summary

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.

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.

Study Design

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

Conditions

Healthy

Intervention

Metformin, Glucophage

Location

Vimta Labs Ltd.
Hyderabad
Andhra pradesh
India
500051

Status

Completed

Source

Dr. Reddy's Laboratories Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:18-0400

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