At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 45 enrolled
Drug / intervention
ondansetron clinical trial formulation +1 moredrug
Likely dose
ondansetron clinical trial formulation 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.
An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study to Determine the Bioequivalence of 2 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects
In Brief
A Phase 1 clinical trial evaluating ondansetron clinical trial formulation and ondansetron marketed formulation for Chemotherapy-Induced Nausea and Vomiting. Completed, enrolled 45 participants.
Detailed Summary
This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a non-U.S. marketed formulation of ondansetron.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChemotherapy-Induced Nausea and Vomiting
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2004
Primary CompletionAug 2004
Study CompletionSep 2004
First PostedSep 2009
TodayJul 2026
First PostedSep 7, 2009
Enrollment StartJun 1, 2004
Primary CompletionAug 1, 2004
Study CompletionSep 1, 2004
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.8 years ago
Interventions
ondansetron clinical trial formulationdrug
Single dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods.
ondansetron marketed formulationdrug
Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods.