Study to Assess Blood Levels of Itraconazole During a Two-Week Period
NCT ID: NCT00695071
Last Updated: 2011-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2008-06-30
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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A
Itraconazole
Oral
Interventions
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Itraconazole
Oral
Eligibility Criteria
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Inclusion Criteria
* Good physical and mental health status, determined on the basis of the medical history and a general clinical examination.
* Vital signs (blood pressure and heart rate) in supine position within the normal range
* Electrocardiogram (12 lead) considered as normal
* Non-smoker.
* Able to swallow pills
* If subject is a woman of childbearing potential (WOCBP), must agree to use adequate birth control as defined by the protocol
Exclusion Criteria
* History or presence of drug abuse or consumption of alcohol
* History of sensitivity or allergy to azoles or related drugs
* Any requirement to be on other drug treatment (except acetaminophen and for WOCBP, hormonal contraceptives)
* Unsuitable veins for repeated venipuncture.
* Clinically significant abnormal ECG
* Nursing mothers and pregnant women, or women of childbearing potential not using adequate contraceptives.
18 Years
55 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Stiefel, a GSK Company
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials, MD
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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Advanced Biomedical Research
Hackensack, New Jersey, United States
Countries
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Other Identifiers
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BT0300-108-USA
Identifier Type: -
Identifier Source: org_study_id