Status:
COMPLETED
Influence of CYP2C19 Genotype on the Pharmacokinetics (PK) of Voriconazole
Lead Sponsor:
Seoul National University Hospital
Conditions:
Healthy
Eligibility:
MALE
20-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to: * Evaluate the influence of CYP2C19 genotype on PK profiles of voriconazole.
Eligibility Criteria
Inclusion
- Healthy male subjects aged 20 - 50 years.
- A body mass index (BMI) in the range 17-28 kg/m2.
- Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.
Exclusion
- Presence or history of severe adverse reaction to any drug or a history of severe allergic disease.
- Clinically relevant abnormal medical history that could interfere with the objectives of the study.
- Presence or history of eye disease or eye field defect.
- A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug.
- A subject whose liver function test (AST, ALT, GGT, ALP, LDH) result is over 1.25 times of upper limit of normal range.
- A subject whose SBP is over 140 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
- Presence or history of drug abuse.
- Participation in other clinical trial within 2 months.
- Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication within 1 week before first dose.
- Blood donation during 2 months or apheresis during 1 month before the study.
- Presence or history of alcohol abuse.
- Smoking of more than 10 cigarettes/day.
- Use of grapefruit juice, xanthine containing beverage, alcohol or smoking during restriction period.
- Subject judged not eligible for study participation by investigator.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00942773
Start Date
December 1 2008
End Date
March 1 2009
Last Update
March 4 2010
Active Locations (1)
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1
Seoul National University Hospital Clinical Trial Center
Seoul, South Korea, 110-744