At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-label Randomized, Two Way Crossover Bioequivalence Study to Compare Ondansetron Orally Dissolving FilmStrip 8mg With Zofran Orally Disintegrating Tablets 8 mg in 48 Healthy, Adult, Participants Under Fed Conditions.
In Brief
A Phase 1 clinical trial evaluating Ondansetron (ODFS) and Ondansetron (ODT) for Healthy. Completed, enrolled 48 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study participants under fed conditions. The purpose is to monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fed conditions.
Study Details
Timeline
Interventions
Ondansetron Orally Dissolving Filmstrip Ondansetron (ODFS)
Ondansetron Orally Disintegrating Tablet Ondanestron (ODT)