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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00695071
First received: June 9, 2008
Last updated: September 23, 2011
Last verified: September 2011
History of Changes

June 9, 2008
September 23, 2011
June 2008
July 2008   (final data collection date for primary outcome measure)
Steady State Plasma levels of Itraconazole [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00695071 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Assess Blood Levels of Itraconazole During a Two-Week Period
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.
Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Healthy
Drug: Itraconazole
Oral
Active Comparator: A
Intervention: Drug: Itraconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00695071
BT0300-108-USA
No
GlaxoSmithKline ( Stiefel, a GSK Company )
Stiefel, a GSK Company
GlaxoSmithKline
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP