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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Stiefel, a GSK Company
• Collaborator: GlaxoSmithKline
• Treatments: Hydroxyitraconazole; Itraconazole

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.