Three-way Crossover Study Comparing Ondansetron ODFS Administered With and Without Water to Zofran ODT Without Water
Condition: Healthy Participants
Intervention: Ondansetron 8 mg ODFS without water; Ondansetron 8 mg ODFS with water; Zofran ODT (ondansetron 8 mg) without water
Intervention description: 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
Intervention MeSH terms: Ondansetron
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
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)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: bioavailability

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.
    

Eligibility criteria:

        Inclusion Criteria:

        The criteria for inclusion in the study were:

          -  Study volunteer should provide written informed consent.

          -  Study volunteer must be a healthy adult within 18-45 years of age (inclusive).

          -  Study volunteer should have a Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with
             body weight not less than 50 kg.

          -  Study volunteer should have a systolic blood pressure with upper limit of less than
             140 mmHg and lower limit of more than or equal to 90 mm Hg.

          -  Study volunteer must be of normal health as determined by medical history and physical
             examination performed within 15 days prior to the dosing of period 1.

          -  Study volunteer should have a normal ECG, chest X-ray and vital signs.

          -  If study volunteer is a female and is of child bearing potential she must be
             practicing an acceptable method of birth control for the duration of the study.

        Exclusion Criteria:

        The criteria for exclusion from the study were:

          -  Study volunteer incapable of understanding the informed consent.

          -  Study volunteer with a history of hypersensitivity or idiosyncratic reaction to study
             drug or any other related drug.

          -  Study volunteer having any evidence of impairment of renal, hepatic, cardiac, lung or
             gastrointestinal function.

          -  Study volunteers with a history of tuberculosis, epilepsy, asthma (during past 5
             years), diabetes, psychosis or glaucoma

          -  Study volunteer who smokes regularly more than ten cigarettes daily.

          -  Study volunteer who has taken over the counter or prescribed medications.

          -  Study volunteer with a history of any psychiatric illness, which may impair the
             ability to provide written, informed consent.