Single-dose cross over comparative bioavailability of Ondansetron 16 mg ODT and Zofran 16 mg
Minimum age: 18 Years.
Maximum age: 55 Years.
- Availability of subject for the entire study period and willingness to adhere to
protocol requirements as evidenced by the informed consent form(ICF) duly signed by
- Males and females aged between 18 and 55 years with a body mass index (BMI) greater
or equal to 19 and below 30 kg/ m2
- Clinical laboratory values within the laboratory's stated normal range; if not within
this range, they must be without any clinical significance(laboratory tests are
presented in section 6. 1.1. 3)
- Healthy according to the laboratory results and physical examination.
- Non- or ex- smokers
- Significant history of hypersensitivity to ondansetron or any related products as
well as severe hypersensitivity reactions (like angioedema) to any drugs.
- Presence or history of significant gastrointestinal, liver or kidney disease, or any
conditions known to interfere with the absorption, distribution, metabolism or
excretion of drugs or known to potentiate or predispose to undesired effects.
- Presence or history of significant cardiovascular, pulmonary, hematologic,
neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
- Females who are pregnant, lactating or are likely to become pregnant during the study
- Females of childbearing potential who refuse to use an acceptable contraceptive
regimen throughout the body.
- Positive serum pregnancy test before and during the study.
- Maintenance therapy with any drug, or significant history or drug dependancy, alcohol
abuse (>3 units of alcohol per day, intake of excessive alcohol, acute or chronic).
- Any clinically significant illness in the previous 28 days before day 1 of this
- Use of enzyme-modifying drugs in the previous 28 days before 1 day of this study (all
barbiturates, corticosteroids, phenylhydantoins, etc.).
- Participation in another clinical trial in the previous 28 days before day 1 of this
- Donation of 500 mL of blood (Canadian Blood Services, Hema-Quebec, clinical studies,
etc.) in the previous 56 days before day 1 of this study.
- Positive urine screening of drugs of abuse (drug names are presented in section
6. 1.1. 4).
- Positive results to HIV, HBsAg or anti-HCV tests.