Ondansetron HCl Orally Disintegrating Tablets Under Fasting Conditions
Condition: Healthy
Intervention: Ondansetron; Zofran®
Intervention description: 1 x 8 mg Orally Disintegrating Tablet; 1 x 8 mg ODT
Intervention MeSH terms: Ondansetron
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects selected for this study will be non-smokers at least 18 years of age.

          -  Subjects will have a BMI (body mass index) of 30 or less.

        Exclusion Criteria:

          -  Subjects with a significant recent history of chronic alcohol consumption, drug
             addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease,
             tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible
             for this study.

          -  Subjects whose clinical laboratory test values are greater than 20% outside the normal
             range may be retested. If the clinical values are outside the range on retesting, the
             subject will not be eligible to participate in the study unless the clinical
             investigator deems the result to not be significant.

          -  Subjects who have a history of allergic responses to the class of drug being tested
             will be excluded from the study.

          -  Subjects who use tobacco in any form will not be eligible to participate in the study.
             Three months abstinence is required.

          -  All subjects will have urine samples assayed for the presence of drugs of abuse as
             part of the clinical laboratory screening procedures and at each dosing period
             check-in. Subjects found to have urine concentrations of any of the tested drugs will
             not be allowed to participate.

          -  Subjects should not have donated blood and/or plasma for at least thirty (30) days
             prior to the first dosing of the study.

          -  Subjects who have taken any investigational drug within thirty (30) days prior to the
             first dosing of the study will not be allowed to participate.

          -  Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant
             during the study will not be allowed to participate. Female subjects of child bearing
             potential must either abstain from sexual intercourse or use a reliable barrier method
             (e.g. condom, IUD) of contraception during the course of the study (first dosing until
             last blood collection) or they will not be allowed to participate. Subjects who have
             used implanted or injected hormonal contraceptives anytime during the 180 days prior
             to study dosing or oral hormonal contraceptives with in 14 days of dosing will not be
             allowed to participate.

          -  All Female subjects will be screened for pregnancy at check-in each study period.
             Subjects with positive or inconclusive results will be withdrawn from the study.

          -  Subjects who do not tolerate venipuncture will not be allowed to participate.