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VIMOVO · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Treatment order : A, B, C |
| 2 | EXPERIMENTAL | Treatment order : B, C, A |
| 3 | EXPERIMENTAL | Treatment order : C, A, B |
| 4 | EXPERIMENTAL | Treatment order : A, C, B |
| 5 | EXPERIMENTAL | Treatment order : B, A, C |
| 6 | EXPERIMENTAL | Treatment order : C, B, A |
| Name | Type | Description |
|---|---|---|
| VIMOVO (AstraZeneca) | DRUG | VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole |
| VIMOVO (Patheon) | DRUG | VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole |
| Marketed enteric-coated naproxen formulation | DRUG | Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet |
Inclusion Criteria: * Healthy male or female volunteer, aged 18 - 55 years (inclusive) * Female volunteers must be non-pregnant and non-lactating and have a negative urine pregnancy test result prior to enrolment into the study. * Female volunteers of childbearing potential must be using appropriat...
VIMOVO is an investigational small molecule being studied in healthy volunteers for bioequivalence. It is a combination product being evaluated to compare formulations manufactured at different sites. The drug is in Phase 1 clinical development and is not approved for any indication.
VIMOVO is being developed by AstraZeneca PLC (ticker: AZN). The company is conducting clinical trials to evaluate the drug's bioequivalence in healthy volunteers.
VIMOVO is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in healthy volunteers for bioequivalence purposes.
VIMOVO has one completed clinical trial, NCT01331993, which was a Phase 1 bioequivalence study comparing VIMOVO manufactured at AstraZeneca AB to VIMOVO manufactured by Patheon Pharmaceuticals and a marketed enteric-coated naproxen formulation. The trial enrolled 36 participants in the United Kingdom.
VIMOVO is not the same as naproxen alone. It is a combination product being studied for bioequivalence against a marketed enteric-coated naproxen formulation. The trial compared VIMOVO from two manufacturing sites to the naproxen reference product.