Phase 1
N=18
Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water
Healthy Participants
Bottom Line
View on ClinicalTrials.gov: NCT01220167 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Cmax — 40.866; 42.843; 39.382 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Ondansetron 8 mg ODFS without water (Drug); Ondansetron 8 mg ODFS with water (Drug); Zofran ODT (ondansetron 8 mg) without water (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aquestive Therapeutics
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax |
40.866; 42.843; 39.382 | — |
| PRIMARY AUCt |
290.687; 291.069; 285.457 | — |
| PRIMARY AUCinf |
311.349; 310.394; 306.497 | — |
Summary
This study conducted in healthy male and female adult participants compared the bioavailability and relative safety and tolerance of a single dose of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS) administered under fasting conditions with and without water with that of a single dose of Zofran Orally Dissolving Tablets (ODT®) containing ondansetron 8 mg administered under fasting conditions without water.
Eligibility Criteria
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 weight not less than 50 kg.
- Study volunteer should have a systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 90 mm Hg.
- Study volunteer must be of normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period 1.
- Study volunteer should have a normal ECG, chest X-ray and vital signs.
- If study volunteer is a female and is of child bearing potential she must be practicing an acceptable method of birth control for the duration of the study.
Exclusion Criteria
The criteria for exclusion from the study were:
- Study volunteer incapable of understanding the informed consent.
- Study volunteer with a history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
- Study volunteer having any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
- Study volunteers with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma
- Study volunteer who smokes regularly more than ten cigarettes daily.
- Study volunteer who has taken over the counter or prescribed medications.
- Study volunteer with a history of any psychiatric illness, which may impair the ability to provide written, informed consent.
Data sourced from ClinicalTrials.gov (NCT01220167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.