NCT03697889

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Naproxen sodium (test product)	Participants will be administered single doses of 275 mg Naproxen sodium (test product) tablet orally.
DRUG	Naproxen sodium (reference product)	Participants will be administered single doses of 275 mg Naproxen sodium (reference product - Nalgesin) tablet orally.

Timeline

• Start date: 2018-12-03
• Primary completion: 2018-12-17
• Completion: 2019-01-21
• First posted: 2018-10-05
• Last updated: 2020-01-23

Locations

1 site across 1 country: Russia