Study to Assess Blood Levels of Itraconazole During a Two-Week Period

Completed · Phase 1

Conditions studied: Healthy

In brief

The objective of this clinical trial is to document the steady state pharmacokinetics and safety of a new itraconazole 200 mg film coated tablet.

Key facts

Study ID

NCT00695071

Run by

Stiefel, a GSK Company

People needed

16

Starts

2008-06-01

Expected to finish

2008-07-01

Last updated by the study team

2011-09-26

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Advanced Biomedical Research — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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