drugset / Trial / NCT00784368

A Pharmacokinetic Study of JK1211(Itraconazole [Itrizole]) Oral Solution in Participants With Deep Mycosis and Those With Febrile Neutropenia Suspected of Fungal Infection

NCT00784368

Phase 3 Completed 55 enrolled Janssen Pharmaceutical K.K.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time) of itraconazole (ITCZ) oral solution in participants with Systemic Fungal Infection (SFI) and those with febrile (with fever) neutropenia (FN, decrease in white blood cells) suspected of fungal infection.

Timeline

Start
2008-01
Primary completion
2009-04
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Itraconazole Small molecule 20 ml Oral
Subject Itraconazole Small molecule 40 ml Oral
Subject Itraconazole Small molecule 200 mg Oral