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Pharmacokinetics of Voriconazole in Obese Subjects

NCT01030653 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-02-09

Study results available
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Summary

Obese subjects may require a higher fixed oral maintenance dosing regimen of voriconazole compared to normal weight subjects to achieve comparable plasma exposures. The current study is designed to address this issue.

Conditions

  • Healthy

Interventions

DRUG

Voriconazole low dose

Voriconazole 400 mg po x 2 doses (loading dose)then 200 mg po twice daily x 7 doses

DRUG

Voriconazole high dose

Voriconazole 400 mg po x 2 doses (loading dose)then 300 mg po twice daily x 7 doses

Sponsors & Collaborators

  • TKL Research, Inc.

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Manjunath Prakash Pai

    lead OTHER

Principal Investigators

  • Manjunath P Pai, PharmD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-04-30
Completion
2010-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT01030653 on ClinicalTrials.gov