Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ondansetron · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Ondansetron | EXPERIMENTAL | Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period |
| Zofran® | ACTIVE_COMPARATOR | Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Ondansetron | DRUG | 1 x 8 mg Orally Disintegrating Tablet |
| Zofran® | DRUG | 1 x 8 mg ODT |
Inclusion Criteria: * All subjects selected for this study will be non-smokers at least 18 years of age. * Subjects will have a BMI (body mass index) of 30 or less. Exclusion Criteria: * Subjects with a significant recent history of chronic alcohol consumption, drug addiction, or serious gastroin...
Ondansetron is a small molecule being developed by Teva Pharmaceutical Industries Limited (TEVA). In the clinical trials listed, it is being studied in healthy volunteers to assess the pharmacokinetics of orally disintegrating tablets under fasting and non-fasting conditions. The drug is currently in Phase 1 clinical development.
Ondansetron is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials to evaluate the drug's orally disintegrating tablet formulation in healthy volunteers.
Ondansetron is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trials are designed to study the drug's behavior in healthy subjects under different dietary conditions.
Ondansetron has two completed Phase 1 clinical trials: NCT00934180, which studied orally disintegrating tablets under fasting conditions, and NCT00934921, which studied the same formulation under non-fasting conditions. Each trial enrolled 24 healthy volunteers in the United States.
Yes, Ondansetron is the same as ondansetron HCl. The clinical trials for Ondansetron evaluate ondansetron HCl orally disintegrating tablets, and the drug is commonly referred to by this name in the study titles.