Phase 4
N=12
To Determine The Amount Of Voriconazole In The Brain After 2 Loading Doses And 3 Maintenance Doses Over 3 Days
Infections, Fungal
Bottom Line
View on ClinicalTrials.gov: NCT00300677 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2009
Primary outcome: Primary: Plasma Concentrations of Voriconazole — 839.50; 2182.33 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- voriconazole (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Pfizer
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Concentrations of Voriconazole |
839.50; 2182.33 | — |
| PRIMARY Brain Concentrations of Voriconazole |
2090.44; 4165.20 | — |
| PRIMARY Plasma Concentrations of N-oxide Metabolite |
3076.67; 3665.00 | — |
| PRIMARY Brain Concentrations of N-oxide Metabolite |
663.97; 1535.40 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00300677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.