At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
Comparator: Treatment A (Zofran, ondansetron) +2 moredrug
Likely dose
Comparator: Treatment A (Zofran, 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.
An Open-Label, Randomized, Single Dose, 3-period Crossover Study to Determine the Bioequivalence of 3 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects
In Brief
A Phase 1 clinical trial evaluating Comparator: Treatment A (Zofran, ondansetron), Comparator: Treatment B (Zofran, ondansetron), and 1 other intervention for Chemotherapy-Induced Nausea and Vomiting. Completed, enrolled 12 participants.
Detailed Summary
This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and 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 StartNov 2003
Primary CompletionDec 2003
Study CompletionJan 2004
First PostedSep 2009
TodayJul 2026
First PostedSep 4, 2009
Enrollment StartNov 1, 2003
Primary CompletionDec 1, 2003
Study CompletionJan 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.8 years ago
Interventions
Comparator: Treatment A (Zofran, ondansetron)drug
an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
Comparator: Treatment B (Zofran, ondansetron)drug
a single 8 mg tablet of Zofran marketed in the U.K., taken PO
Comparator: Treatment C (Zofran, ondansetron)drug
a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO