NCT00945321

A Study to Assess the Bioequivalence of Aprepitant and Fosaprepitant and the Effect of Food on Aprepitant Bioavailability (0869-165)

A Single-Dose Bioequivalence and Food Effect Study With Aprepitant and Fosaprepitant Dimeglumine in Healthy Young Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chemotherapy-Induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	aprepitant 165 mg	Single dose of aprepitant 165 mg tablet in the fasted state during treatment period 1,2, or 3.
DRUG	Comparator: aprepitant 185 mg	Single dose of aprepitant 185 mg tablet in the fasted state during treatment period 1, 2, or 3.
DRUG	Comparator: fosaprepitant 150 mg	Single dose of fosaprepitant 150 mg intravenous infusion in the fasted state during treatment period 1,2, or 3.
DRUG	Comparator: aprepitant with food	Single dose of aprepitant 165 mg or 185 mg tablet in the fed state during treatment period 4.

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2009-07-24
• Last updated: 2015-01-28
• Results posted: 2010-06-30