CI

At a glance

ClinicalIndex Comparison Record
Phase 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.

Search/NCT00934180
NCT00934180Phase 1Completed
CompareCT.gov

A Relative Bioavailability Study of Ondansetron HCl 8 mg Orally Disintegrating Tablets Under Fasting Conditions

Teva Pharmaceuticals USA·interventional·Posted Jul 8, 2009·Updated Aug 21, 2024

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 fasting conditions in healthy, non-smoking adult subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 8, 2009
Enrollment StartDec 1, 2002
Primary CompletionDec 1, 2002
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