NCT01331993

A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation

A Phase I, Open-label, Randomised, 3-way Crossover Study to Demonstrate Bioequivalence of a Single Oral Dose of Naproxen Administered as VIMOVO Manufactured at AstraZeneca AB Compared to That of VIMOVO Manufactured by Patheon Pharmaceuticals and a Marketed Enteric-coated Naproxen Formulation (Manufactured by Roche) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary purpose is to demonstrate the bioequivalence of naproxen administered as VIMOVO manufactured at a new facility in Sweden (AstraZeneca) to that of naproxen administered as VIMOVO manufactured in the USA (Patheon) and to a marketed enteric-coated naproxen formulation.

Detailed description

A Phase I, Open-label, Randomised, 3-way Crossover Study to demonstrate Bioequivalence of a Single Oral Dose of Naproxen administered as VIMOVO manufactured at AstraZeneca AB compared to that of VIMOVO manufactured by Patheon Pharmaceuticals and a marketed enteric-coated Naproxen Formulation (Manufactured by Roche) in Healthy Volunteers.

Conditions

• Healthy Volunteers
• Bioequivalence

Interventions

Type	Name	Description
DRUG	VIMOVO (AstraZeneca)	VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole
DRUG	VIMOVO (Patheon)	VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole
DRUG	Marketed enteric-coated naproxen formulation	Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-04-08
• Last updated: 2011-10-18

Locations

1 site across 1 country: United Kingdom