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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00992381 | Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone | PHASE1 | COMPLETED | 24 | — | — | Sep 1, 2009 | Oct 1, 2009 | Jan 18, 2010 | 1 | Australia |
| NCT00907400 | Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Naprosyn E | PHASE1 | COMPLETED | 48 | — | — | May 1, 2009 | Sep 1, 2009 | Dec 10, 2010 | 2 | Sweden |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | PN400 |
| 2 | ACTIVE_COMPARATOR | Naproxen |
| Name | Type | Description |
|---|---|---|
| PN400 | DRUG | 500mg Naproxen and 20mg esomeprazole |
| Naprosyn | DRUG | 500mg Naproxen |
| Naproxen | DRUG | oral tablet |
Inclusion Criteria: * Subjects must have a body weight greater than 50 kg and BMI within the range 18-30(inclusive). * Subjects must be in good health, as assessed during pre-study medical examination and by review of screening results * Subjects must understand the procedures involved and agree to...