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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00934921 | Ondansetron HCl Orally Disintegrating Tablets Under Non-Fasting Conditions | PHASE1 | COMPLETED | 24 | — | — | Feb 1, 2003 | Feb 1, 2003 | Aug 21, 2024 | 1 | United States |
| NCT00934180 | Ondansetron HCl Orally Disintegrating Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 24 | — | — | Dec 1, 2002 | Dec 1, 2002 | Aug 21, 2024 | 1 | United States |
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Ondansetron | EXPERIMENTAL | Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period |
| Zofran® | ACTIVE_COMPARATOR | Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Ondansetron | DRUG | 1 x 8 mg Orally Disintegrating Tablet |
| Zofran® | DRUG | 1 x 8 mg ODT |
Inclusion Criteria: * All subjects selected for this study will be non-smokers at least 18 years of age. * Subjects will have a BMI (body mass index) of 30 or less. Exclusion Criteria: * Subjects with a significant recent history of chronic alcohol consumption, drug addiction, or serious gastroin...