Official Title: “Assessment of the Steady State Pharmacokinetics of Itraconazole and Hydroxy-Itraconazole in Healthy Subjects After Administration of a New Itraconazole 200 mg Film Coated Tablet Once Daily for Fourteen Days in Fed Condition”

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

Study Type: Interventional

Study Design: Other, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study

Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

• Drug: Itraconazole
  • Oral

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A

Primary Measures

• Steady State Plasma levels of Itraconazole
  • Time Frame: 2 weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Barrier Therapeutics

Overall Clinical Trial Officials and Contacts

Ben Roesch, MD Principal Investigator Advanced Biomedical Research  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00695071

Study ID Number: BT0300-108-USA

ClinicalTrials.gov Identifier: NCT00695071

Health Authority: United States: Food and Drug Administration