Ondansetron HCl Orally Disintegrating Tablets Under Fasting Conditions
- Conditions
- Healthy
- Registration Number
- NCT00934180
- Lead Sponsor
- Teva Pharmaceuticals USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria:<br><br> - All subjects selected for this study will be non-smokers at least 18 years of age.<br><br> - Subjects will have a BMI (body mass index) of 30 or less.<br><br>Exclusion Criteria:<br><br> - Subjects with a significant recent history of chronic alcohol consumption, drug<br> addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease,<br> tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible<br> for this study.<br><br> - Subjects whose clinical laboratory test values are greater than 20% outside the<br> normal range may be retested. If the clinical values are outside the range on<br> retesting, the subject will not be eligible to participate in the study unless the<br> clinical investigator deems the result to not be significant.<br><br> - Subjects who have a history of allergic responses to the class of drug being tested<br> will be excluded from the study.<br><br> - Subjects who use tobacco in any form will not be eligible to participate in the<br> study. Three months abstinence is required.<br><br> - All subjects will have urine samples assayed for the presence of drugs of abuse as<br> part of the clinical laboratory screening procedures and at each dosing period<br> check-in. Subjects found to have urine concentrations of any of the tested drugs<br> will not be allowed to participate.<br><br> - Subjects should not have donated blood and/or plasma for at least thirty (30) days<br> prior to the first dosing of the study.<br><br> - Subjects who have taken any investigational drug within thirty (30) days prior to<br> the first dosing of the study will not be allowed to participate.<br><br> - Female subjects who are pregnant, breast-feeding, or who are likely to become<br> pregnant during the study will not be allowed to participate. Female subjects of<br> child bearing potential must either abstain from sexual intercourse or use a<br> reliable barrier method (e.g. condom, IUD) of contraception during the course of the<br> study (first dosing until last blood collection) or they will not be allowed to<br> participate. Subjects who have used implanted or injected hormonal contraceptives<br> anytime during the 180 days prior to study dosing or oral hormonal contraceptives<br> with in 14 days of dosing will not be allowed to participate.<br><br> - All Female subjects will be screened for pregnancy at check-in each study period.<br> Subjects with positive or inconclusive results will be withdrawn from the study.<br><br> - Subjects who do not tolerate venipuncture will not be allowed to participate.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax - Maximum Observed Concentration;AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated);AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
- Secondary Outcome Measures
Name Time Method