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To Determine The Amount Of Voriconazole In The Brain After 2 Loading Doses And 3 Maintenance Doses Over 3 Days

Last updated on December 17, 2017

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Study Location
Pfizer Investigational Site
Belmont, Massachusetts, 02478-1041 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fungal Infections
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects with any condition affecting drug absorption.

NCT00300677
Pfizer
Completed
To Determine The Amount Of Voriconazole In The Brain After 2 Loading Doses And 3 Maintenance Doses Over 3 Days

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To Determine The Amount Of Voriconazole In The Brain After 2 Loading Doses And 3 Maintenance Doses Over 3 Days
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Infections, Fungal
Drug: voriconazole
Multiple oral doses of voriconazole at 400 mg loading twice daily followed by 200 mg maintenance twice daily
Other Name: Vfend
Experimental: voriconazole
voriconazole twice daily
Intervention: Drug: voriconazole
Henry ME, Bolo NR, Zuo CS, Villafuerte RA, Cayetano K, Glue P, Damle BD, Andrews E, Lauriat TL, Rana NS, Churchill JH, Renshaw PF. Quantification of brain voriconazole levels in healthy adults using fluorine magnetic resonance spectroscopy. Antimicrob Agents Chemother. 2013 Nov;57(11):5271-6. doi: 10.1128/AAC.00394-13. Epub 2013 Aug 12.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
August 2008
August 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00300677
A1501079
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
McLean Hospital. Belmont, MA.
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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