An open label randomised, two-treatment,two-period, two-sequence, single-dose, crossover, comparative bioequivalence study.
The study was an open label, randomised, two-treatment,two-period, two-sequence, single-dose, crossover,comparative bioequivalence study of Naproxen Sodium 550 mg tablets (containing naproxen 500 mg) manufactured by Dr. Reddy's Laboratories, ltd, Generics, India compared with ANAPROX® DS 550 mg tablets (containing naproxen 500 mg) of Roche Pharmaceuticals, Roche Laboratories Inc. 340 Kingsland Street, New Jersey; in healthy,adult, human subjects under fed conditions with a wash out period of 10 days between two periods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Naproxen Sodium Tablets 550 mg
Wellquest Clinical Research
Mumbai, Maharashtra, India
Bioequivalence based on Cmax and AUC parameters
Time frame: 3 months
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