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

Stiefel

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00695071

BT0300-108-USA

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

16 participants in 1 patient group

A

Active Comparator group

Treatment:

Drug: Itraconazole