Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01331993 | A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation | PHASE1 | COMPLETED | 36 | — | — | Sep 1, 2011 | Oct 1, 2011 | Oct 18, 2011 | 1 | United Kingdom |
| 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...