Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

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).
    

Intervention name(s): Ondansetron 8 mg ODFS without water; Ondansetron 8 mg ODFS with water; Zofran ODT (ondansetron 8 mg) without water
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of Ondansetron 8 mg (ODFS) administered without water; Single dose of Ondansetron 8 mg (ODSF) was orally administered, allowed to dissolve, swallowed with saliva, followed with water; Single dose of Zofran ODT (containing ondansetron 8 mg) administered without water
Other intervention name(s): Test Treatment (A); Test Treatment (B); Reference Treatment (C)
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Open label, balanced, randomized three period, three treatment, three sequence, three-way crossover bioavailability study .
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioavailability