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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00947063 | To Demonstrate the Relative Bioavailability Study of Promethazine HCl 50 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 36 | — | — | Jul 1, 2004 | Aug 1, 2004 | Mar 28, 2017 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Promethazine HCl 50 mg Tablets (Sandoz, Inc) |
| 2 | ACTIVE_COMPARATOR | Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories) |
| Name | Type | Description |
|---|---|---|
| Promethazine HCl 50 mg Tablets (Sandoz, Inc) | DRUG | - |
| Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories) | DRUG | - |
Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.