NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedPhase 1

Sponsor: Stiefel, a GSK Company

Conditions: Healthy

Interventions: Itraconazole

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Hackensack, New Jersey, United States