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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00946387 | To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 26 | — | — | Sep 1, 2004 | Sep 1, 2004 | Mar 28, 2017 | - | — |
| NCT00947128 | To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions | PHASE1 | COMPLETED | 26 | — | — | Sep 1, 2004 | Oct 1, 2004 | Mar 28, 2017 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Ondansetron HCl 24 mg Tablets (Sandoz, Inc.) |
| 2 | ACTIVE_COMPARATOR | Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline) |
| Name | Type | Description |
|---|---|---|
| Ondansetron HCl 24 mg Tablets (Sandoz, Inc.) | DRUG | - |
| Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline) | 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.