Status:
COMPLETED
Study to Assess Blood Levels of Itraconazole During a Two-Week Period
Lead Sponsor:
Stiefel, a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00695071
Start Date
June 1 2008
End Date
July 1 2008
Last Update
September 26 2011
Active Locations (1)
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1
Advanced Biomedical Research
Hackensack, New Jersey, United States, 07601