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Also known as ZOFRAN™
ondansetron clinical trial formulation · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | clinical trial formulation |
| B | ACTIVE_COMPARATOR | non-U.S. marketed formulation |
| Name | Type | Description |
|---|---|---|
| ondansetron clinical trial formulation | DRUG | Single dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods. |
| ondansetron marketed formulation | DRUG | Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods. |
Inclusion Criteria: * If female, subject is not pregnant or breast-feeding * Subject has been a nonsmoker for at least 6 months * Subject is in good health Exclusion Criteria: * Subject has a history of high blood pressure, asthma, other pulmonary disease, Gastrointestinal (GI) abnormalities/pept...
Ondansetron clinical trial formulation refers to a specific oral formulation of ondansetron studied in a Phase 1 bioequivalence trial. The trial compared two formulations of ondansetron in healthy adults to assess whether they behave similarly in the body. It was sponsored by Merck & Company, Inc. and completed with 45 participants.
Ondansetron targets the HTR3A receptor, also known as the 5-HT3A receptor. It acts as an antagonist at this receptor, blocking serotonin signaling. This mechanism underlies its use in preventing chemotherapy-induced nausea and vomiting. The target class is antagonist, and the drug is a small molecule.
Merck & Company, Inc. is the developer of this ondansetron clinical trial formulation. The company is publicly traded under the ticker MRK. The formulation was evaluated in a company-sponsored Phase 1 trial.
Ondansetron clinical trial formulation is in Phase 1 development. The only listed trial for this formulation is a completed Phase 1 bioequivalence study. It is an investigational formulation and is not described as approved in this dataset.
Ondansetron clinical trial formulation was studied in one clinical trial: NCT00972595, titled Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106). The trial was Phase 1, completed, randomized, active-controlled, and enrolled 45 healthy adult volunteers. It evaluated bioequivalence between two ondansetron formulations.
Ondansetron clinical trial formulation is intended for chemotherapy-induced nausea and vomiting. The Phase 1 trial listed for this formulation was conducted in healthy adult volunteers to assess bioequivalence, not to treat patients. The therapeutic area is classified as other.