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.
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 fasting conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Nabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited
Relafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC.
Bioserve Clinical Research Pvt. Ltd.
Hyderabad, Andhra Pradesh, India
Bioequivalence study is based on Cmax and AUC parameters
Time frame: 1 month
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