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A Study to Assess Bioquivalence Between a Novel Naproxen Sodium 275 mg Film-coated Tablet and Nalgesin Naproxen Sodium 275 mg Film-coated Tablet in Healthy Adult Volunteers

Healthy Clinical Trial

Official title:
An Open-label, Randomized, Single-dose, Two-treatment, Crossover Bioequivalence Study Comparing a Novel Naproxen Sodium 275 mg Film-coated Tablet (BILIM ILAC SANAYII VE TICARET A.S., TURKEY) and Nalgesin® 275 mg Naproxen Sodium Film-coated Tablet (JSC "KRKA, D.D., NOVO MESTO", SLOVENIA), in Healthy Adult Volunteers

Clinical Trial Summary

This is a research study designed to evaluate the rate and extent of absorption of Naproxen from a novel Naproxen sodium tablet and Nalgesin naproxen sodium 275 mg.

Clinical Trial Description

The study has an open-label, randomized, two-way crossover design. 28 healthy participants will be included. Single-doses of 1 tablet of Naproxen sodium 275 mg and Nalgesin 275 mg will be given on separate treatment visits to healthy adult participants under fasting conditions. A crossover design is chosen in order to allow within-subject comparisons of treatments. To minimize the risk of carry-over effect, the washout period between the study drug administrations is set to 7 days. The study is open-label because the primary data collected are concentration measurements that cannot be expected to be affected by a participant's knowledge of the product administered. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03697889
Study type Interventional
Source Johnson & Johnson Consumer and Personal Products Worldwide
Contact
Status Completed
Phase Phase 1
Start date December 3, 2018
Completion date January 21, 2019
View Details
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