The objective of this clinical trial is to document the steady state pharmacokinetics and
safety of a new itraconazole 200 mg film coated tablet.
- 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
- 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,
- Unsuitable veins for repeated venipuncture.
- Clinically significant abnormal ECG
- Nursing mothers and pregnant women, or women of childbearing potential not using