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

NCT00945321 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2015-01-28

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-03-31
Completion
2009-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00945321 on ClinicalTrials.gov