Expired Study
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Hackensack, New Jersey 07601


The objective of this clinical trial is to document the steady state pharmacokinetics and safety of a new itraconazole 200 mg film coated tablet.


Inclusion Criteria: - BMI between 18.0 and 28.0 kg/m2 - 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: - Any disease or physical condition which, in the opinion of the investigator, could impact the pharmacokinetics of the drug - 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.



Primary Contact:

Study Director
GSK Clinical Trials, MD

Backup Contact:


Location Contact:

Hackensack, New Jersey 07601
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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