NCT03167541

Naproxen Sodium (2 x 220 mg) Fasted Comparative Bioavailability Study

A Randomised, Single-dose, 2-way Crossover, Open-label, Comparative Bioavailability Study Comparing Test Naproxen Sodium Tablets (2 x 220 mg) With Commercially Available Reference Naproxen Sodium Tablets (2 x 220 mg) in the Fasted State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Reckitt Benckiser Healthcare (UK) Limited · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to investigate the rate and extent of naproxen absorption from the Test naproxen sodium formulation is bioequivalent to Aleve® naproxen sodium, a Reference product currently marketed in The Netherlands in order to support the registration of the Reckitt Benckiser (RB) naproxen sodium (220 mg tablets).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Test	RB naproxen sodium tablets (2x220mg)
DRUG	Reference	Aleve naproxen sodium tablets (2x220mg)

Timeline

• Start date: 2016-10-12
• Primary completion: 2016-12-02
• Completion: 2016-12-02
• First posted: 2017-05-30
• Last updated: 2019-02-28
• Results posted: 2019-02-28