NCT01220167

Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Aquestive Therapeutics · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This was an open-label, single oral dose,randomized sequence, three-way crossover study to compare the bioavailability, safety and tolerability of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS) administered without (Test Treatment A) and with water (Test Treatment B) with that of Zofran Orally Dissolving Tablets (ODT®) containing ondansetron 8 mg administered without water (Reference Treatment C) in healthy adult participants. The 3 treatment sequences were: ABC, BCA, and CAB, in which, all treatments were administered after an overnight fasting of at least 10 hours in each period. Participants reported to the study site between 07:30 am to 04:30 pm on 22 Aug 2008, 25 Aug 2008, and 28 Aug 2008 for Period 1, Period 2, \& Period 3, respectively. Participants were served dinner between 8:00 pm to 8:30 pm, to ensure a minimum of 10 hours of fasting prior to administration of a single dose of either the test or reference product. Participants were dosed as per the randomization schedule with a 3-day wash out period between each administration. A total of 18 blood samples (4 mL each) were collected from each subject in each period for pharmacokinetic analyses. Safety assessments including monitoring of adverse events, periodic physical examination, and vital signs monitoring. Urine Drug Screening was done at the time of check-in of all the study periods to identify participants with any substance abuse. Urine pregnancy screen (for female subjects only) was scheduled at the time of screening and at admission for Period 1, Period 2, Period 3. A clinical assessment, which included general and systemic examination, was done at the pre-study screening and post study physical examination. Clinical laboratory hematology and chemistry tests were performed at screening (pre-study) and at the study follow-up visit (post-study).

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Ondansetron 8 mg ODFS without water	Single dose of Ondansetron 8 mg (ODFS) administered without water
DRUG	Ondansetron 8 mg ODFS with water	Single dose of Ondansetron 8 mg (ODSF) was orally administered, allowed to dissolve, swallowed with saliva, followed with water
DRUG	Zofran ODT (ondansetron 8 mg) without water	Single dose of Zofran ODT (containing ondansetron 8 mg) administered without water

Timeline

• Start date: 2008-08-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2010-10-13
• Last updated: 2020-08-18
• Results posted: 2020-08-18