Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ondansetron Orally Disintegrating · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Ondansetron Orally Disintegrating Tablets 8 mg |
| 2 | ACTIVE_COMPARATOR | Zofran ODT® Tablets 8 mg |
| Name | Type | Description |
|---|---|---|
| Ondansetron Orally Disintegrating Tablets 8 mg | DRUG | 8mg, single dose fed |
| Zofran ODT® Tablets 8 mg | DRUG | 8mg, single dose fed |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 21 days prior to the start of the study and on the ev...
Ondansetron Orally Disintegrating is an investigational small molecule being studied in healthy volunteers. It is being developed by Viatris Inc. (VTRS) as an orally disintegrating tablet formulation. The drug is currently in Phase 1 clinical development, with studies evaluating its pharmacokinetics compared to a reference product.
Ondansetron Orally Disintegrating is being developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker VTRS. The company is conducting Phase 1 clinical trials to evaluate the drug's performance in healthy subjects.
Ondansetron Orally Disintegrating is in Phase 1 clinical development. Two Phase 1 studies have been completed, both involving healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
Ondansetron Orally Disintegrating has two completed Phase 1 trials: NCT00648804, a food study comparing the 8 mg orally disintegrating tablet to Zofran ODT 8 mg, and NCT00649363, a fasting study with the same comparison. Each trial enrolled 28 healthy participants in the United States.
Ondansetron Orally Disintegrating is being studied as a potential generic equivalent to Zofran ODT. The Phase 1 trials compare the 8 mg orally disintegrating tablet to Zofran ODT 8 mg under fed and fasting conditions to assess bioequivalence.