A Study to Assess the Bioequivalence of Aprepitant and Fosaprepitant and the Effect of Food on Aprepitant Bioavailability (0869-165)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00945321|
Recruitment Status : Completed
First Posted : July 24, 2009
Results First Posted : June 30, 2010
Last Update Posted : January 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy-Induced Nausea and Vomiting||Drug: aprepitant 165 mg Drug: Comparator: aprepitant 185 mg Drug: Comparator: fosaprepitant 150 mg Drug: Comparator: aprepitant with food||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Dose Bioequivalence and Food Effect Study With Aprepitant and Fosaprepitant Dimeglumine in Healthy Young Adult Subjects|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
Active Comparator: 1
aprepitant 165 mg
Drug: aprepitant 165 mg
Single dose of aprepitant 165 mg tablet in the fasted state during treatment period 1,2, or 3.
Active Comparator: 2
aprepitant 185 mg
Drug: Comparator: aprepitant 185 mg
Single dose of aprepitant 185 mg tablet in the fasted state during treatment period 1, 2, or 3.
fosaprepitant 150 mg
Drug: Comparator: fosaprepitant 150 mg
Single dose of fosaprepitant 150 mg intravenous infusion in the fasted state during treatment period 1,2, or 3.
aprepitant with food
Drug: Comparator: aprepitant with food
Single dose of aprepitant 165 mg or 185 mg tablet in the fed state during treatment period 4.
- Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg [ Time Frame: Through 72 Hours Postdose ]
- Peak Plasma Concentration (Cmax) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg. [ Time Frame: Through 72 Hours Postdose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945321
|Study Director:||Medical Monitor||Merck Sharp & Dohme LLC|