Study to Assess Blood Levels of Itraconazole During a Two-Week Period
Information source: Barrier Therapeutics
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Itraconazole (Drug)
Phase: Phase 1
Status: Enrolling by invitation
Sponsored by: Barrier Therapeutics Official(s) and/or principal investigator(s):
Ben Roesch, MD, Principal Investigator, Affiliation: Advanced Biomedical Research
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.
Clinical Details
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
Study design: Other, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study
Primary outcome: Steady State Plasma levels of Itraconazole
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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 and Contacts
Advanced Biomedical Research, Hackensack, New Jersey 07601, United States
Additional Information
Starting date: June 2008
Ending date: July 2008
Last updated: June 10, 2008
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