The objective of this clinical trial is to document the steady state pharmacokinetics and safety of a new itraconazole 200 mg film coated tablet.
No linked publications found in PubMed
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.