CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Ondansetron 8 mg ODFS without water +2 moredrug
Likely dose
Ondansetron 8 mg ODFS without waterfrom record
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Search/NCT01220167
NCT01220167Phase 1Completed
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Open-label, Randomized, Three-way Crossover Bioavailability Study Comparing Ondansetron Orally Dissolving Filmstrip (ODFS) With and Without Water to Zofran Orally Dissolving Tablets (ODT) Without Water in Healthy Adult Study Participants

Aquestive Therapeutics·interventional·Posted Oct 13, 2010·Updated Aug 18, 2020

In Brief

A Phase 1 clinical trial evaluating Ondansetron 8 mg ODFS without water, Ondansetron 8 mg ODFS with water, and 1 other intervention for Healthy Participants. Completed, enrolled 18 participants.

Detailed Summary

This study conducted in healthy male and female adult participants compared the bioavailability and relative safety and tolerance of a single dose of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS) administered under fasting conditions with and without water with that of a single dose of Zofran Orally Dissolving Tablets (ODT®) containing ondansetron 8 mg administered under fasting conditions without water.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Participants
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 13, 2010
Enrollment StartAug 1, 2008
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 15.7 years ago

Interventions

Ondansetron 8 mg ODFS without waterdrug

Single dose of Ondansetron 8 mg (ODFS) administered without water

Ondansetron 8 mg ODFS with waterdrug

Single dose of Ondansetron 8 mg (ODSF) was orally administered, allowed to dissolve, swallowed with saliva, followed with water

Zofran ODT (ondansetron 8 mg) without waterdrug

Single dose of Zofran ODT (containing ondansetron 8 mg) administered without water