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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00650403 | Food Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg | PHASE1 | COMPLETED | 66 | — | — | Dec 1, 2006 | Jan 1, 2007 | Apr 24, 2024 | 1 | United States |
| NCT00647881 | Food Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CR™ Tablets 25 mg | PHASE1 | COMPLETED | 75 | — | — | Apr 1, 2005 | May 1, 2005 | Apr 24, 2024 | 1 | United States |
| NCT00648427 | Fasting Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CR™ Tablets 25 mg | PHASE1 | COMPLETED | 75 | — | — | Apr 1, 2005 | May 1, 2005 | Apr 24, 2024 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Paroxetine hydrochloride 40 mg tablet |
| 2 | ACTIVE_COMPARATOR | Paxil® 40 mg Tablet |
| Name | Type | Description |
|---|---|---|
| Paroxetine hydrochloride 40 mg tablet | DRUG | 40mg, single dose fed |
| Paxil® 40 mg Tablet | DRUG | 40mg, single dose fed |
| Paroxetine Hydrochloride Controlled-Release Tablets 25 mg | DRUG | 25mg, single dose fed |
| Paxil CR™ Tablets 25 mg | DRUG | 25mg, single dose fed |
Inclusion Criteria: 1. Subjects who were informed of the nature of the study and agreed to read, review, and sign the informed consent document prior to Period I dosing. 2. Subjects who completed the screening process within 21 days prior to Period I dosing. 3. Subjects who were healthy adult men a...