Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00784368 | A Pharmacokinetic Study of JK1211(Itraconazole [Itrizole]) Oral Solution in Participants With Deep Mycosis and Those With Febrile Neutropenia Suspected of Fungal Infection | PHASE3 | COMPLETED | 55 | — | — | Jan 1, 2008 | May 1, 2009 | Jul 25, 2013 | 1 | Japan |
The Cmax is defined as the maximum observed analyte concentration. Cmax was measured in microgram per milliliter (mcg/ml).
The AUC(0-24) is area under the plasma concentration time curve from time zero (pre-dose) to 24 hours post-dose. It is usually calculated by linear trapezoidal method. AUC was measured in mcg\*hour(hr) per ml.
The MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation.
The Cmax is maximum observed analyte concentration and MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The Cmax/MIC was calculated only in participants for whom the MIC was obtained.
The AUC (0-24) is defined as area under the plasma concentration-time curve over the dosing interval (24 hr). It is usually calculated by linear trapezoidal method. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The AUC 0-24/MIC was calculated only in participants for whom the MIC was obtained.
The T\>MIC was calculated only in participants for whom the MIC was obtained.
| Arm | Type | Description |
|---|---|---|
| SFI (ITCZ Oral Solution Monotherapy) | EXPERIMENTAL | Participants with deep-seated mycosis (Systemic Fungal Infection \[SFI\]) received itraconazole (ITCZ) oral solution in the dose range of 20 milliliter (ml) per day to 40 ml per day for 12 weeks as per Investigator's discretion. |
| SFI (Switched Treatment) | EXPERIMENTAL | Participants with SFI received 200 milligram (mg) twice daily itraconazole intravenous (into the vein) infusion (ITCZ-IV) for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator's discretion. |
| FN (Switched treatment) | EXPERIMENTAL | Participants with febrile neutropenia (FN) with suspected fungal infection received 200 mg twice daily ITCZ-IV for first 2 days followed by 200 mg per day ITCZ-IV up to 14 days. Participants then received ITCZ oral solution in the dose range of 20 ml per day to 40 ml per day for 12 weeks as per Investigator's discretion. |
| Name | Type | Description |
|---|---|---|
| ITCZ Oral Solution | DRUG | ITCZ syrup product containing ITCZ 10 mg per ml in dose range of 20 ml to 40 ml daily for 7 days up to 12 weeks |
| ITCZ-IV | DRUG | 200 mg IV twice daily for 2 days and once daily for the next 1 to 12 days |
Inclusion Criteria: * In case of participants with deep-seated mycosis (systemic fungal infection \[SFI\]) they should be either clinically suspected case or proven case * All participants administered need to be hospitalized during the itraconazole intravenous treatment * For participants with feb...