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...
Date First Received: March 7, 2006
Last Updated: July 30, 2008
Verified by: Pfizer, July 2008
Clinical Trial Phase: Phase 4 | Start Date: March 2006
Overall Status: Recruiting
Estimated Enrollment: 12
Brief Summary
Official Title: “Assessment Of Voriconazole Penetration Into The Brain By Fluorine-Magnetic Resonance Spectroscopy.”
Condition Keyword(s):
Intervention(s):
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
Intervention(s) in this Clinical Trial
- Drug: voriconazole
- Multiple oral doses of voriconazole at 400 mg loading twice daily followed by 200 mg maintainence twice daily
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: voriconazole
- voriconazole twice daily
Outcome Measures for this Clinical Trial
Primary Measures
- Levels in the brain and plasma
- Time Frame: 3 days
Safety Issue?: No
- Time Frame: 3 days
Secondary Measures
- Safety and tolerability
- Time Frame: 3 days
Safety Issue?: No
- Time Frame: 3 days
Criteria for Participation in this Clinical Trial
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
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
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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