Study to Assess Blood Levels of Itraconazole During a Two-Week Period
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Assessment of the Steady State Pharmacokinetics of Itraconazole and Hydroxy-Itraconazole in Healthy Subjects After Administration of a New Itraconazole 200 mg Film Coated Tablet Once Daily for Fourteen Days in Fed Condition
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
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Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
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.