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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01220167 | Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water | PHASE1 | COMPLETED | 18 | — | — | Aug 1, 2008 | Aug 1, 2008 | Aug 18, 2020 | - | — |
Maximum Plasma Concentration (Time to reach maximum concentration)
Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (e.g., "0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose")
Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity
| Arm | Type | Description |
|---|---|---|
| Sequence ABC | EXPERIMENTAL | Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses. |
| Sequence BCA | EXPERIMENTAL | Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses. |
| Sequence CAB | EXPERIMENTAL | Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses. |
| Name | Type | Description |
|---|---|---|
| Ondansetron 8 mg ODFS without water | DRUG | Single dose of Ondansetron 8 mg (ODFS) administered without water |
| Ondansetron 8 mg ODFS with water | DRUG | Single dose of Ondansetron 8 mg (ODSF) was orally administered, allowed to dissolve, swallowed with saliva, followed with water |
| Zofran ODT (ondansetron 8 mg) without water | DRUG | Single dose of Zofran ODT (containing ondansetron 8 mg) administered without water |
Inclusion Criteria: The criteria for inclusion in the study were: * Study volunteer should provide written informed consent. * Study volunteer must be a healthy adult within 18-45 years of age (inclusive). * Study volunteer should have a Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body we...