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Ondansetron · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Ondansetron Tablets 24 mg |
| 2 | ACTIVE_COMPARATOR | Zofran® Tablets 24 mg |
| Name | Type | Description |
|---|---|---|
| Ondansetron Tablets 24 mg | DRUG | 24mg, single dose fed |
| Zofran® Tablets 24 mg | DRUG | 24mg, single dose fed |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male or non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration...
Ondansetron is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is currently in Phase 1 clinical development. The specific medical conditions it is being studied for have not been disclosed. It is an antagonist that targets the HTR3A receptor.
Ondansetron targets the HTR3A receptor, also known as the 5-HT3 receptor. It acts as an antagonist at this target. This mechanism of action is characteristic of the drug class to which Ondansetron belongs.
Ondansetron is being developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the clinical development of this drug candidate.
Ondansetron is in Phase 1 clinical development. The available trials are early-stage studies, and the drug has not been approved by the FDA for any indication. It remains an investigational product.
Ondansetron has been studied in two completed Phase 1 trials: NCT00649532, a fasting study, and NCT00648583, a food study. Both trials enrolled 28 healthy volunteers each in the United States and compared Ondansetron Tablets 24 mg to Zofran Tablets 24 mg.