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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


NCT number NCT03697889
Study type Interventional
Source Johnson & Johnson Consumer and Personal Products Worldwide
Contact Magdalena Krol
Phone +48 784 001 162
Email mkrol2@its.jnj.com
Status Not yet recruiting
Phase Phase 1
Start date November 4, 2018
Completion date March 31, 2019

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