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Ondansetron · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Ondansetron HCl 24 mg Tablets (Sandoz, Inc.) |
| 2 | ACTIVE_COMPARATOR | Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline) |
| Name | Type | Description |
|---|---|---|
| Ondansetron HCl 24 mg Tablets (Sandoz, Inc.) | DRUG | - |
| Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline) | DRUG | - |
Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.
Ondansetron is used for nausea, and the trials listed for this asset also include vomiting among the conditions studied. It is a small molecule developed by Novartis AG under the ticker NVS. The two registered studies enrolled healthy volunteers rather than patients seeking treatment for an active condition.
Ondansetron targets HTR3A, the serotonin 3 receptor subunit, and acts as an antagonist at that target. Antagonism of HTR3A is the mechanism associated with this small molecule. The target class recorded for ondansetron is antagonist, and its ChEMBL identifier is CHEMBL46.
Ondansetron is developed by Novartis AG, which trades under the ticker NVS. The asset is also known as Ondansetron HCl 24 mg Tablets (Sandoz, Inc.), so readers searching under that Sandoz product name are looking at the same ondansetron asset described here.
Ondansetron is in Phase 1 development for nausea, and it is an investigational asset rather than an approved product in this development program. Both registered trials are Phase 1 studies and both are completed, with no active trials currently listed for this asset.
Two completed Phase 1 trials are registered for ondansetron: NCT00947128, a relative bioavailability study of ondansetron HCl 24 mg tablets under non-fasting conditions, and NCT00946387, the same bioavailability study under fasting conditions. Each trial enrolled 26 healthy volunteers, for a total enrollment of 52 participants.
Both ondansetron trials were randomized, active-controlled Phase 1 bioavailability studies in healthy volunteers, and neither was double blind. NCT00947128 enrolled 26 participants aged 20 years and older, and NCT00946387 enrolled 26 participants aged 22 years and older. Both studies are completed and included nausea and vomiting among the conditions studied.