Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ondansetron ODFS without water · 1 trial · 1 indication
Maximum Plasma Concentration (Time to reach maximum concentration)
Area Under Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (e.g., "0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose")
Area Under Plasma Concentration-Time Curve From Time Zero to Time Infinity
| Arm | Type | Description |
|---|---|---|
| Sequence ABC | EXPERIMENTAL | Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses. |
| Sequence BCA | EXPERIMENTAL | Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses. |
| Sequence CAB | EXPERIMENTAL | Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water), Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water). Each dose was administered following a 10-hour fast with a 3-day washout period between doses. |
| Name | Type | Description |
|---|---|---|
| Ondansetron 8 mg ODFS without water | DRUG | Single dose of Ondansetron 8 mg (ODFS) administered without water |
| Ondansetron 8 mg ODFS with water | DRUG | Single dose of Ondansetron 8 mg (ODSF) was orally administered, allowed to dissolve, swallowed with saliva, followed with water |
| Zofran ODT (ondansetron 8 mg) without water | DRUG | Single dose of Zofran ODT (containing ondansetron 8 mg) administered without water |
Inclusion Criteria: The criteria for inclusion in the study were: * Study volunteer should provide written informed consent. * Study volunteer must be a healthy adult within 18-45 years of age (inclusive). * Study volunteer should have a Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body we...
Ondansetron ODFS without water is an orally disintegrating film formulation of ondansetron designed to be taken without water. It is being developed by Aquestive Therapeutics, Inc. (ticker AQST) and is also referred to as Ondansetron 8 mg ODFS without water. It is a small molecule in Phase 1 clinical development.
Ondansetron ODFS without water targets HTR3A, the 5-HT3A serotonin receptor, and acts as an antagonist at this target. Blocking HTR3A is the established mechanism for ondansetron-based therapies. The drug is a small molecule developed as an orally disintegrating film.
Ondansetron ODFS without water is being developed by Aquestive Therapeutics, Inc., which trades under the ticker AQST. The company is the sponsor of the clinical program for this orally disintegrating film formulation of ondansetron.
Ondansetron ODFS without water is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The program has completed one Phase 1 trial, and no active trials are currently listed.
Ondansetron ODFS without water has been studied in one completed Phase 1 trial, NCT01220167. That trial was a three-way crossover study comparing Ondansetron ODFS administered with and without water to Zofran ODT without water. It enrolled 18 healthy participants, was randomized and controlled, and did not use blinding.