NCT00175994

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.) 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2005

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

April 17, 2007

Status Verified

April 1, 2007

First QC Date

September 12, 2005

Last Update Submit

April 16, 2007

Conditions

Healthy

Keywords

voriconazolegenotypebioavailabilitymetabolic clearance

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good state of health (physically and mentally)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Unit, Department Internal Medicine VI

Heidelberg, 69120, Germany

Location

Study Officials

  • Gerd Mikus, MD BSc

    Department Internal Medicine VI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

July 1, 2005

Study Completion

July 1, 2006

Last Updated

April 17, 2007

Record last verified: 2007-04

Locations

DE(1)