Bioavailability and Metabolism of Voriconazole in Relation to Its Modulation by the CYP2C19 Genetic Polymorphism
The purposes of this study are:
- To determine the absolute bioavailability of voriconazole after a single oral dose (400 mg voriconazole [VFEND brand]) in comparison to intravenous (i.v.) administration (400 mg VFEND, equivalent to two 10 mg/ml-infusates, each containing 200 mg voriconazole [VRC]) in healthy individuals stratified according to the three predominant CYP2C19 genotypes
- To investigate the possible pathways of metabolism and their modulation according to genetic polymorphism of CYP2C19 after i.v. and oral administration of VRC.
|Study Design:||Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
|Official Title:||Bioavailability and Metabolism of Voriconazole as a Function of the CYP2C19 Genotype|
|Study Start Date:||July 2005|
|Study Completion Date:||July 2006|
As CYPs are mainly involved in VRC metabolism it is likely that also gut wall metabolism by CYPs occurs. However, no substantial first pass metabolism of VRC has been reported. In humans the VRC metabolism has not been studied systematically. It is therefore important to assess VRC metabolism on its own and in addition the influence of CYP2C19 genetic polymorphisms on the formation of the different VRC metabolites.
|Clinical Research Unit, Department Internal Medicine VI|
|Heidelberg, Germany, 69120|
|Principal Investigator:||Gerd Mikus, MD BSc||Department Internal Medicine VI|