NCT01164826

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

A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover Bioequivalence Study of Nabumetone 750 mg Tablets of Dr. Reddy's and Relafen® 750 mg Tablets of Glaxosmithkline, in Healthy Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 fed conditions with a washout period of 16 days. * To monitor adverse events and ensure the safety of subjects.

Detailed description

A randomized, open label, two treatment, two period, two sequence, single dose crossover, bioequivalence study of nabumetone 750 mg tablets of Dr. Reddy's Laboratories Limited and Relafen® 750 mg tablets of Glaxosmithkline research triangle park, in healthy, adult, human subjects under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Nabumetone	Nabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited
DRUG	Relafen	Relafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC.

Timeline

• Start date: 2006-03-01
• Primary completion: 2006-03-01
• Completion: 2006-03-01
• First posted: 2010-07-19
• Last updated: 2010-07-19

Locations

1 site across 1 country: India