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Also known as Ondansetron (ODFS)
Ondansetron · 1 trial · 2 indications
Maximum Plasma Concentration occurring at Tmax (Time to reach maximum concentration)
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| Arm | Type | Description |
|---|---|---|
| Ondansetron ODFS then Zofran ODT | EXPERIMENTAL | Single dose of Ondansetron Orally Dissolving Film Strip 8 mg followed by single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg with 7 days washout between the 2 periods |
| Zofran ODT then Ondansetron ODFS | EXPERIMENTAL | Single dose of Zofran ODT® Orally Disintegrating Tablet containing Ondansetron 8 mg followed by single dose of Ondansetron Orally Dissolving Film Strip 8 mg with 7 days washout between the 2 periods |
| Name | Type | Description |
|---|---|---|
| Ondansetron (ODFS) | DRUG | Test Article |
| Zofran (ODT) | DRUG | Comparator |
Inclusion Criteria: * Volunteer should have written informed consent. * Volunteer healthy adult within 18-45 years of age (inclusive). * Body mass index of 18.5 kg/m\^2 and 25 kg/m\^2, body weight not less than 50 kg. * Volunteer must be of normal health. * Volunteer should have a normal ECG, chest...
Ondansetron is used to treat nausea and vomiting, including postoperative nausea and vomiting. The formulation described here is an orally dissolving film strip being developed by Aquestive Therapeutics under the name Ondansetron (ODFS). It is a small molecule 5-HT3 receptor antagonist given to adults.
Ondansetron targets HTR3A, the 5-HT3A serotonin receptor, and acts as an antagonist at that receptor. Blocking this receptor reduces the nausea and vomiting signals that serotonin triggers, which is the basis for its use in postoperative nausea and vomiting and chemotherapy-induced nausea and vomiting.
Ondansetron (ODFS) is being developed by Aquestive Therapeutics, Inc., which trades on the Nasdaq under the ticker AQST. The company is developing the orally dissolving film strip formulation of ondansetron as an alternative to existing orally disintegrating tablet forms.
Ondansetron (ODFS) is in Phase 1 clinical development. It is an investigational formulation and is not described as approved. The Phase 1 work completed to date was a single crossover study conducted in healthy adult volunteers.
Ondansetron (ODFS) has been studied in one completed Phase 1 trial, NCT01217190, titled a crossover study comparing ondansetron orally dissolving film strip (ODFS) with Zofran orally disintegrating tablets. That trial enrolled 48 healthy adult volunteers in India, was randomized and controlled, and has completed.
Ondansetron (ODFS) refers to an orally dissolving film strip formulation of ondansetron developed by Aquestive Therapeutics. Ondansetron is the active drug substance, while ODFS identifies the specific film strip dosage form studied in the Phase 1 crossover trial against Zofran orally disintegrating tablets.