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
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
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie ondansetron's antiemetic effects in chemotherapy-induced nausea and vomiting?
How does the Merck clinical trial formulation of ondansetron compare in effectiveness to standard-of-care 5-HT3 receptor antagonists for CINV management?
Are there specific biomarkers that can predict individual response to ondansetron formulations in preventing CINV?
What are the known adverse events associated with ondansetron formulations and how can they be managed in clinical practice?
How do combination approaches involving ondansetron and other antiemetic agents improve outcomes in chemotherapy-induced vomiting compared to monotherapy?