Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ondansetron · 2 trials · 3 indications
Calculation of the AUC-Time Curve will be conducted to determine bio-equivalence.
Maximum Plasma Concentration occurring at Tmax (Time to reach maximum concentration)
Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration
Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity
| Arm | Type | Description |
|---|---|---|
| Ondansetron (ODFS) | EXPERIMENTAL | single dose of Ondansetron Orally Dissolving Filmstrip 8 mg |
| Zofran (ODT) | ACTIVE_COMPARATOR | Single dose of Zofran (Ondansetron) ODT Orally Disintegrating Tablets 8 mg |
| 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 | Ondansetron Orally Dissolving Filmstrip Ondansetron (ODFS) |
| Ondansetron (ODT) | DRUG | Ondansetron Orally Disintegrating Tablet Ondanestron (ODT) |
| Zofran (ODT) | DRUG | Comparator |
Inclusion Criteria: * provide written informed consent. * healthy adult within 18-45 years of age (inclusive). * Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg. * systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equ...
Ondansetron is used for nausea and vomiting, including postoperative nausea and vomiting and chemotherapy-induced nausea with vomiting. It is also studied in healthy volunteers for bioequivalence purposes. The drug is being developed by Aquestive Therapeutics, Inc. as an orally dissolving film strip formulation.
Ondansetron is a small molecule that works as a serotonin 5-HT3 receptor antagonist. It blocks the action of serotonin, a chemical that can trigger nausea and vomiting, thereby preventing these symptoms. This mechanism is relevant for its use in postoperative and chemotherapy-induced nausea and vomiting.
Ondansetron is being developed by Aquestive Therapeutics, Inc., a company traded under the ticker symbol AQST. The company is working on an orally dissolving film strip formulation of ondansetron, which is currently in Phase 1 clinical development.
Ondansetron is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The clinical trials for this formulation are completed, with a total of 48 participants enrolled across two studies.
Ondansetron has been studied in two completed Phase 1 trials: NCT01217190, a crossover study comparing ondansetron orally dissolving film strip with Zofran orally disintegrating tablets, and NCT01217801, a two-way bioequivalence study under fed conditions. Both trials enrolled 48 healthy volunteers in India.
Ondansetron is the active ingredient in Zofran, but the product being developed by Aquestive Therapeutics is a different formulation. The clinical trial NCT01217190 directly compares the orally dissolving film strip of ondansetron with Zofran orally disintegrating tablets to assess bioequivalence.