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

NCT01160042 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2010-07-26

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Metformin

Metformin Tablets 1000 mg

DRUG

Glucophage

Glucophage 1000 mg tablets of Bristol-Myers Squibb

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Mangesh Kulkarni, MD · Vimta Labs Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2005-04-30
Completion
2005-04-30

Countries

  • India

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01160042 on ClinicalTrials.gov