A Study to Assess the Bioequivalence of Aprepitant and Fosaprepitant and the Effect of Food on Aprepitant Bioavailability (0869-165)
Phase 1
Completed
- Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Interventions
- Registration Number
- NCT00945321
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study will assess the bioequivalence of single oral doses of aprepitant (MK0869) to a single intravenous infusion of fosaprepitant (MK0517) and also determine the effect of food on the bioavailability of oral aprepitant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
- Subject is in good health
- Subject is a nonsmoker
- Subject is willing to comply with the study restrictions
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Exclusion Criteria
- Subject has a history of any illness that might confound the results of the study or might make participation in the study unsafe
- Subject has a history of stroke, seizures, or major neurological disorder
- Subject has a history of cancer
- Subject consumes more than two alcoholic drinks per day
- Subject consumes more than three caffeinated beverages daily
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 aprepitant 165 mg aprepitant 165 mg
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg. Through 72 Hours Postdose Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg Through 72 Hours Postdose
- Secondary Outcome Measures
Name Time Method