Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01572012 | Phase 1 Safety, Tolerability and PK Study of Ondansetron and Hylenex Recombinant in Healthy Volunteers | PHASE1 | COMPLETED | 12 | — | — | Feb 1, 2012 | Nov 1, 2013 | Jan 24, 2014 | 1 | United States |
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...