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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00972595 | Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106) | PHASE1 | COMPLETED | 45 | — | — | Jun 1, 2004 | Sep 1, 2004 | Aug 19, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | clinical trial formulation |
| B | ACTIVE_COMPARATOR | non-U.S. marketed formulation |
| Name | Type | Description |
|---|---|---|
| ondansetron clinical trial formulation | DRUG | Single dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods. |
| ondansetron marketed formulation | DRUG | Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods. |
Inclusion Criteria: * If female, subject is not pregnant or breast-feeding * Subject has been a nonsmoker for at least 6 months * Subject is in good health Exclusion Criteria: * Subject has a history of high blood pressure, asthma, other pulmonary disease, Gastrointestinal (GI) abnormalities/pept...