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Bioequivalence Study of Nabumetone 750 mg Tablets of Dr. Reddy's Under Fasting Conditions

NCT01164813 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2010-07-19

No results posted yet for this study

Summary

The purpose of this study is:

* To Assess the bioequivalence study of Nabumetone 750 mg tablets and Relafen® 750 mg tablets in healthy, adult, human subjects under fasting conditions with a washout period of 14 days.
* To monitor adverse events and ensure the safety of subjects.

Conditions

  • Healthy

Interventions

DRUG

Nabumetone

Nabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited

DRUG

Relafen

Relafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC.

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Mohan lal Siva Prasad Sayana · Bioserve Clinical Research Private Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2006-03-31
Completion
2006-03-31

Countries

  • India

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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 NCT01164813 on ClinicalTrials.gov