At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 48 enrolled
Drug / intervention
Ondansetron (ODFS) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-Label Randomized, Single Oral Dose, Two-Way Crossover Bioequivalence Study Comparing Ondansetron Orally Dissolving Film Strip 8 mg With Zofran Orally Disintegrating Tablets (ODT) (Containing Ondansetron 8 mg) in Healthy Adults
In Brief
A Phase 2 clinical trial evaluating Ondansetron (ODFS) and Zofran (ODT) for Nausea and Vomiting, Postoperative and Nausea With Vomiting Chemotherapy-Induced. Completed, enrolled 48 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2008
Primary CompletionSep 2008
Study CompletionOct 2008
First PostedOct 2010
TodayJul 2026
First PostedOct 8, 2010
Enrollment StartSep 16, 2008
Primary CompletionSep 26, 2008
Study CompletionOct 6, 2008
TodayJul 2, 2026
Enrollment to primary: 10 daysPosted 15.7 years ago
Interventions
Ondansetron (ODFS)drug
Test Article
Zofran (ODT)drug
Comparator