At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Ondansetron +1 moredrug
Likely dose
Ondansetron 8 mgfrom 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.
A Relative Bioavailability Study of Ondansetron HCl 8 mg Orally Disintegrating Tablets Under Non-Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Ondansetron and Zofran® for Healthy. Completed, enrolled 24 participants across 1 site.
Detailed Summary
The objective of this study was to compare the relative bioavailability of the test formulation of Ondansetron HCl with the already marketed reference formulation Zofran® ODT under non-fasting conditions in healthy, non-smoking, adult subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2003
Primary CompletionFeb 2003
First PostedJul 2009
TodayJul 2026
First PostedJul 8, 2009
Enrollment StartFeb 1, 2003
Primary CompletionFeb 1, 2003
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.0 years ago
Interventions
Ondansetrondrug
1 x 8 mg Orally Disintegrating Tablet
Zofran®drug
1 x 8 mg ODT