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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00971633 | A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED) | PHASE1 | COMPLETED | 12 | — | — | Nov 1, 2003 | Jan 1, 2004 | Sep 14, 2016 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Treatment Sequence A-B-C |
| 2 | EXPERIMENTAL | Treatment Sequence B-C-A |
| 3 | EXPERIMENTAL | Treatment Sequence C-A-B |
| 4 | EXPERIMENTAL | Treatment Sequence A-C-B |
| 5 | EXPERIMENTAL | Treatment Sequence B-A-C |
| 6 | EXPERIMENTAL | Treatment Sequence C-B-A |
| Name | Type | Description |
|---|---|---|
| Comparator: Treatment A (Zofran, ondansetron) | DRUG | an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO) |
| Comparator: Treatment B (Zofran, ondansetron) | DRUG | a single 8 mg tablet of Zofran marketed in the U.K., taken PO |
| Comparator: Treatment C (Zofran, ondansetron) | DRUG | a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO |
Inclusion Criteria: * If female, subject is not pregnant or breast-feeding * Subject is a nonsmoker * Subject is in good general health Exclusion Criteria: * Subject has a history of high blood pressure, asthma, or cardiovascular, liver, neurologic, or kidney disease * Subject is taking prescript...