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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 a small molecule drug developed by Viatris Inc. (ticker: VTRS). It is an orally disintegrating tablet formulation of ondansetron, given as 8 mg. The drug is in Phase 1 clinical development, and its specific indications are undisclosed.
Ondansetron Orally Disintegrating targets HTR3A, the 5-HT3A receptor. It acts as an antagonist at this target, meaning it blocks serotonin signaling through the receptor. This mechanism underlies its pharmacological activity.
Ondansetron Orally Disintegrating is developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the company responsible for the development of this orally disintegrating tablet formulation.
Ondansetron Orally Disintegrating is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The program includes two completed Phase 1 trials, with no active trials currently listed.
Ondansetron Orally Disintegrating has been studied in two completed Phase 1 trials: NCT00649363, a fasting study, and NCT00648804, a food study. Both compared the 8 mg orally disintegrating tablets to Zofran ODT 8 mg tablets in healthy volunteers, enrolling 28 participants each in the United States.