Status:
COMPLETED
Bioavailability and Metabolism of Voriconazole in Relation to Its Modulation by the CYP2C19 Genetic Polymorphism
Lead Sponsor:
Heidelberg University
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Brief Summary
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.) administ...
Detailed Description
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 metab...
Eligibility Criteria
Inclusion
- Good state of health (physically and mentally)
Exclusion
- Any regular drug treatment within the last two months except for oral contraceptives in female participants
- Any intake of a substance known to induce or inhibit drug metabolising enzymes or transport system enzymes within a period of less than 10 times the respective elimination half-life
- Any acute or chronic illness or clinically relevant findings in the pre-study examination
- Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions
- Smoking (regular or irregular)
- Excessive alcohol drinking (more than approximately 30 g alcohol per day)
- Positive drug screening or known or admitted drug abuse
Key Trial Info
Start Date :
July 1 2005
Trial Type :
OBSERVATIONAL
End Date :
July 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00175994
Start Date
July 1 2005
End Date
July 1 2006
Last Update
April 17 2007
Active Locations (1)
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1
Clinical Research Unit, Department Internal Medicine VI
Heidelberg, Germany, 69120