NCT01052129

Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fasting Condition

Open Label Randomised,Two-treatment,Two-period,Two-sequence,Single-dose, Crossover,Comparative Bioequivalence Study of Naproxen Sodium 550 mg Tablets With ANAPROX® DS 550 mg Tablets in Healthy,Adult, Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

An open label randomised, two-treatment, two-period, two-sequence, single-dose, crossover, comparative bioequivalence study.

Detailed description

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® OS 550 mg tablets (containing naproxen 500 mg) of Roche Pharmaceuticals, Roche Laboratories Inc. 340 Kingsland Street, Newjersy; in healthy,adult, human subjects under fasting conditions with a wash out period of 10 days between two periods.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Naproxen sodium	Naproxen Sodium Tablets 550 mg

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2010-01-20
• Last updated: 2010-05-27

Locations

1 site across 1 country: India