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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00648583 | Food Study of Ondansetron Tablets 24 mg and Zofran® Tablets 24 mg | PHASE1 | COMPLETED | 28 | — | — | Jul 1, 2003 | Jul 1, 2003 | Apr 24, 2024 | 1 | United States |
| NCT00649532 | Fasting Study of Ondansetron Tablets 24 mg and Zofran® Tablets 24 mg | PHASE1 | COMPLETED | 28 | — | — | Jul 1, 2003 | Jul 1, 2003 | Apr 24, 2024 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Ondansetron Tablets 24 mg |
| 2 | ACTIVE_COMPARATOR | Zofran® Tablets 24 mg |
| Name | Type | Description |
|---|---|---|
| Ondansetron Tablets 24 mg | DRUG | 24mg, single dose fed |
| Zofran® Tablets 24 mg | DRUG | 24mg, single dose fed |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male or non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration...