Study to Assess Blood Levels of Itraconazole During a Two-Week Period
- Registration Number
- NCT00695071
- Lead Sponsor
- Stiefel, a GSK Company
- Brief Summary
The objective of this clinical trial is to document the steady state pharmacokinetics and safety of a new itraconazole 200 mg film coated tablet.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Itraconazole -
- Primary Outcome Measures
Name Time Method Steady State Plasma levels of Itraconazole 2 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Advanced Biomedical Research
🇺🇸Hackensack, New Jersey, United States