Phase 2
N=48
Crossover Study Comparing Ondansetron Orally Dissolving Film Strip (ODFS) With Zofran Orally Disintegrating Tablets
Nausea and Vomiting, Postoperative · Nausea With Vomiting Chemotherapy-Induced
Bottom Line
View on ClinicalTrials.gov: NCT01217190 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Cmax — 37.282; 41.108 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ondansetron (ODFS) (Drug); Zofran (ODT) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- MonoSol Rx
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax |
37.282; 41.108 | — |
| PRIMARY AUCt |
216.269; 239.463 | — |
| PRIMARY AUCinf |
225.032; 250.673 | — |
Summary
This was an open-label, balanced, two-treatment, two-period, randomized sequence crossover bioequivalence study with a 7-day washout between periods. Each treatment was administered after an overnight (10 hours) fast.
Eligibility Criteria
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 X-ray and vital signs.
- If study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study.
Criteria: Exclusion Criteria:
- Volunteer doesn't understand the informed consent.
- Volunteer with a history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
- Volunteer having any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function, by standard laboratory, imaging or monitoring procedures
- Volunteer who smokes regularly, alcohol or drug abuse
- Volunteer who has taken over the counter or prescribed medications
- Volunteer with clinically significant abnormal values of laboratory parameters.
- Volunteer who has participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
- Female volunteer demonstrating a positive pregnancy screen with urine pregnancy test (strip method).
Data sourced from ClinicalTrials.gov (NCT01217190). 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.