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Ondansetron · 1 trial · 1 indication
Investigator assessment of infusion site observations for parenteral administration; Subject assessment of pain using the verbal response scale for parenteral administration; Subject assessment of pain using the visual analog scale for parenteral administration; Investigator assessment of systemic adverse events
| Arm | Type | Description |
|---|---|---|
| Subcutaneous Administration | EXPERIMENTAL | Ondansetron + Hylenex administered subcutaneously |
| Oral Administration | EXPERIMENTAL | Ondansetron administered orally |
| Intramuscular Administration | EXPERIMENTAL | Ondansetron administered intramuscularly |
| Intravenous Administration | EXPERIMENTAL | Ondansetron administered intravenously |
| Name | Type | Description |
|---|---|---|
| Ondansetron | DRUG | Ondansetron solution 4 mg single administration |
| Ondansetron + Hylenex | DRUG | Ondansetron solution (4 mg) single administration + Hylenex recombinant (150 U) single administration |
| Zofran ODT | DRUG | Zofran ODT (8 mg) single administration |
| Ondansetron solution | DRUG | Ondansetron solution (4 mg) single administration |
Inclusion Criteria: * Male or female volunteers 19-65 years old * Females must be nonlactating and nonpregnant (negative serum pregnancy test at screening)and agree to practice effective birth control for at least 30 days after study completion * Nonsmoker or no tobacco/nicotine use in previous 6 m...
Ondansetron is being studied in healthy volunteers in a Phase 1 clinical trial to evaluate its safety, tolerability, and pharmacokinetics when administered with Hylenex Recombinant. The study enrolled 12 participants in the United States and has been completed.
Ondansetron is being developed by Halozyme Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol HALO. The company is conducting clinical research on this small molecule drug.
Ondansetron is in Phase 1 clinical development. A Phase 1 study has been completed, which focused on safety, tolerability, and pharmacokinetics in healthy volunteers. The drug remains investigational and is not yet approved for any use.
Ondansetron has one completed clinical trial, identified as NCT01572012. This Phase 1 study, titled 'Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy Volunteers,' enrolled 12 participants in the United States.
No, Ondansetron is not the same as Hylenex Recombinant. In the clinical trial NCT01572012, Ondansetron was studied in combination with Hylenex Recombinant, which is a separate drug product. The trial evaluated the safety and pharmacokinetics of this combination in healthy volunteers.