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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00749359 | PAXIL CR Bioequivalence Study | PHASE1 | COMPLETED | 166 | — | — | Jul 7, 2008 | Sep 16, 2008 | Aug 4, 2017 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| open label treatment | EXPERIMENTAL | On each treatment period, subjects will receive controlled release paroxetine 37.5 milligram (mg) on Day 1. |
| Name | Type | Description |
|---|---|---|
| Paxil CR | DRUG | Paxil CR 37mg tablet manufactures at two different sites |
Key Inclusion: Healthy males or females between 18-65. Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-30 kg/m2. Willing to use acceptable forms of birth control throughout the study. Normal labs and ECG. Key Exclusion: Positive test for drugs or alcohol. Positive for Hepatitis...