Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions (NCT00653458) | Clinical Trial Compass
CompletedPhase 1
Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions
18 participantsStarted 2002-08
Plain-language summary
To compare the single-dose bioavailability of Ondansetron ODT 8 mg and Zofran 8 mg
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Subjects meeting all of the following criteria may be included in the study
* Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent from duly signed by the subject.
* Males and females aged from 18 to 50 years with a body mass index (BMI) within 19-30; demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report.
* Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without ant clinical significance and must be recorded as such in the CRF ( laboratory tests are presented in section 7.1.3)
* Healthy according to the laboratory results and physical examination.
* Normal cardiovascular function according to the to ECG.
* Non or ex-smokers.
Exclusion Criteria:
* 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 other 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 pregnant, lactating or…