A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)
Phase 1
Completed
- Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Registration Number
- NCT00971633
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- If female, subject is not pregnant or breast-feeding
- Subject is a nonsmoker
- Subject is in good general health
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Exclusion Criteria
- Subject has a history of high blood pressure, asthma, or cardiovascular, liver, neurologic, or kidney disease
- Subject is taking prescription or nonprescription drugs that can not be discontinued during the study
- Subject is a habitual and heavy consumer of caffeine
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) of Ondansetron 24 hours post dose Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose
- Secondary Outcome Measures
Name Time Method