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Also known as ondansetron disintegrating tablet - oral
Zofran ODT · 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...
Zofran ODT is an orally disintegrating tablet form of ondansetron, a small molecule drug. It is being studied by Halozyme Therapeutics, Inc. in a Phase 1 clinical program. The specific indication being pursued has not been disclosed.
Zofran ODT is being developed by Halozyme Therapeutics, Inc., which trades on the Nasdaq under the ticker HALO. The company is the sponsor of the clinical program evaluating this orally disintegrating tablet formulation.
Zofran ODT is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program has not been approved by the FDA and remains investigational.
Zofran ODT has been evaluated in one completed Phase 1 trial, NCT01572012, titled a Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy Volunteers. The trial enrolled 12 healthy adult volunteers in the United States and was controlled and randomized.
Zofran ODT is an orally disintegrating tablet formulation containing ondansetron as the active small molecule. The completed Phase 1 trial, NCT01572012, studied ondansetron together with Hylenex recombinant in healthy volunteers, linking the Zofran ODT program to the ondansetron active ingredient.
The specific therapeutic use of Zofran ODT in this development program has not been disclosed. The completed Phase 1 trial, NCT01572012, was conducted in healthy volunteers rather than in a patient population, so no disease indication is identified for this program.