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 investigational small molecule being developed by Aquestive Therapeutics, Inc. (AQST). It is a formulation of ondansetron designed to be administered without water. It is currently in Phase 1 clinical development for use in healthy participants.
Ondansetron ODFS without water is being studied for use in healthy participants. The completed Phase 1 trial evaluated the drug in healthy volunteers to assess its pharmacokinetics and tolerability. Its intended therapeutic use has not been specified in the available clinical trial information.
Ondansetron ODFS without water is being developed by Aquestive Therapeutics, Inc., a company traded under the ticker symbol AQST. The company is conducting clinical research on this formulation of ondansetron.
Ondansetron ODFS without water is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The only clinical trial listed for this drug is a Phase 1 study that has been completed.
Ondansetron ODFS without water has one completed clinical trial, NCT01220167, titled "Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water." This Phase 1 study enrolled 18 healthy participants and was a controlled, randomized trial.
Ondansetron ODFS without water is not the same as Zofran ODT. It is a distinct formulation of ondansetron being developed by Aquestive Therapeutics. The completed Phase 1 trial compared Ondansetron ODFS administered with and without water to Zofran ODT without water, indicating they are separate products.