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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 being developed by Viatris Inc. (VTRS). It is currently in Phase 1 clinical development, studied in healthy volunteers. The drug is being evaluated in clinical trials to assess its pharmacokinetics and bioequivalence compared to a reference product.
Ondansetron is being developed by Viatris Inc., a pharmaceutical company traded on the NASDAQ under the ticker symbol VTRS. The company is conducting Phase 1 clinical trials to evaluate the drug in healthy volunteers.
Ondansetron is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Two Phase 1 trials have been completed, both involving healthy volunteers.
Ondansetron has completed two Phase 1 clinical trials. NCT00648583 is a food study of Ondansetron tablets 24 mg compared to Zofran tablets 24 mg. NCT00649532 is a fasting study of the same products. Both trials enrolled 28 healthy participants each in the United States.
Ondansetron is being studied as a generic version of Zofran. The clinical trials compare Ondansetron tablets 24 mg to Zofran tablets 24 mg to evaluate bioequivalence under fed and fasting conditions.