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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01217190 | Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets | PHASE1 | COMPLETED | 48 | — | — | Sep 16, 2008 | Oct 6, 2008 | Jul 29, 2020 | 1 | India |
Maximum Plasma Concentration occurring at Tmax (Time to reach maximum concentration)
Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration
Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity
| Arm | Type | Description |
|---|---|---|
| Ondansetron ODFS then Zofran ODT | EXPERIMENTAL | Single dose of Ondansetron Orally Dissolving Film Strip 8 mg followed by single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg with 7 days washout between the 2 periods |
| Zofran ODT then Ondansetron ODFS | EXPERIMENTAL | Single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg followed by single dose of Ondansetron Orally Dissolving Film Strip 8 mg with 7 days washout between the 2 periods |
| Name | Type | Description |
|---|---|---|
| Ondansetron (ODFS) | DRUG | Test Article |
| Zofran (ODT) | DRUG | Comparator |
Inclusion Criteria: * Volunteer should have written informed consent. * Volunteer healthy adult within 18-45 years of age (inclusive). * Body mass index of 18.5 kg/m\^2 and 25 kg/m\^2, body weight not less than 50 kg. * Volunteer must be of normal health. * Volunteer should have a normal ECG, chest...