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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Treatment order : A, B, C |
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| 2 | Experimental | Treatment order : B, C, A |
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| 3 | Experimental | Treatment order : C, A, B |
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| 4 | Experimental | Treatment order : A, C, B |
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| 5 | Experimental | Treatment order : B, A, C |
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| 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIMOVO (AstraZeneca) | Drug | VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in area under the plasma concentration-time curve (AUC) from time zero to infinity | Pre-dose to Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Adverse Events as a measure of Safety and Tolerability | Day 1 | |
| Number of subjects with Adverse Events as a measure of Safety and Tolerability | Day 2 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stepehn Kanes | AstraZeneca, Wilmington, USA | Study Director |
| Kingsley Urakpo, MD | Quintiles Drug Research Unit at Guy's Hospital, 6 Newcomen St, London SE1 1YR, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
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| Experimental |
Treatment order : C, B, A |
|
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| VIMOVO (Patheon) | Drug | VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole |
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| Marketed enteric-coated naproxen formulation | Drug | Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet |
|
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| Number of subjects with Adverse Events as a measure of Safety and Tolerability |
| Day 3 |
| Number of subjects with Adverse Events as a measure of Safety and Tolerability | Day 4 |