Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)
Phase 1
Completed
- Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Interventions
- Registration Number
- NCT00972595
- 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 non-U.S. marketed formulation of ondansetron.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- If female, subject is not pregnant or breast-feeding
- Subject has been a nonsmoker for at least 6 months
- Subject is in good health
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Exclusion Criteria
- Subject has a history of high blood pressure, asthma, other pulmonary disease, Gastrointestinal (GI) abnormalities/peptic ulcers, or cardiovascular, liver, neurologic, or kidney disease
- Subject is a habitual and heavy consumer of caffeine
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A ondansetron clinical trial formulation clinical trial formulation B ondansetron marketed formulation non-U.S. marketed formulation
- Primary Outcome Measures
Name Time Method Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose Peak Plasma Concentration (Cmax) for Ondansetron 24 hours post-dose
- Secondary Outcome Measures
Name Time Method