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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00695071
Enrollment
16
Registered
2008-06-11
Start date
2008-06-30
Completion date
2008-07-31
Last updated
2011-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy Volunteers

Brief 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.

Interventions

DRUGItraconazole

Oral

Sponsors

GlaxoSmithKline
CollaboratorINDUSTRY
Stiefel, a GSK Company
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
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.

Design outcomes

Primary

MeasureTime frame
Steady State Plasma levels of Itraconazole2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026