Healthy Participants Clinical Trial
Official title:
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
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.
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).
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