Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Hackensack, New Jersey 07601


Purpose:

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


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.


NCT ID:

NCT00695071


Primary Contact:

Study Director
GSK Clinical Trials, MD
GlaxoSmithKline


Backup Contact:

N/A


Location Contact:

Hackensack, New Jersey 07601
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.