Last reviewed · How we verify
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
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.
Details
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 36 |
| Start date | 2011-09 |
| Completion | 2011-10 |
Conditions
- Healthy Volunteers
- Bioequivalence
Interventions
- VIMOVO (AstraZeneca)
- VIMOVO (Patheon)
- Marketed enteric-coated naproxen formulation
Primary outcomes
- Change in area under the plasma concentration-time curve (AUC) from time zero to infinity — Pre-dose to Day 4
Countries
United Kingdom