Official Title: “Assessment Of Voriconazole Penetration Into The Brain By Fluorine-Magnetic Resonance Spectroscopy.”

To determine the amount of voriconazole in the brain after 2 loading doses and 3 maintenance doses over 3 days and compare it to the amount of voriconazole in the plasma.

Study Type: Interventional

Study Design: Basic Science, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Drug: voriconazole
  • Multiple oral doses of voriconazole at 400 mg loading twice daily followed by 200 mg maintenance twice daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: voriconazole
  • voriconazole twice daily

Primary Measures

• Levels in the brain and plasma
  • Time Frame: 3 days
    Safety Issue?: No

Secondary Measures

• Safety and tolerability
  • Time Frame: 3 days
    Safety Issue?: No

Inclusion Criteria:

• Subjects must be willing and able to provide informed consent.
• Subjects must be willing and able to be confined at the Clinical Research Unit as required by the protocol.

Exclusion Criteria:

• Subjects with any condition affecting drug absorption.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00300677

Study ID Number: A1501079

ClinicalTrials.gov Identifier: NCT00300677

Health Authority: United States: Food and Drug Administration

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