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A pilot study was performed to evaluate the appropriateness of the voriconazole dosing regimen based on the population pharmacokinetic model and the influence of sex on the pharmacokinetics of voriconazole
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voriconazole TBD mg tablet orally, every 12 hours for 7 days | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voriconazole Oral Product (Vfend®) | Drug | To be determined mg of Voriconazole (Vfend®, anti-fungal agent) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) | Pharmacokinetic sampling after administration of drugs from day 1 to day 7 | Day 1 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours, Day 5 12 hours, Day 6 0, 12 hours, Day 7 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours |
| Area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast) | Pharmacokinetic sampling after administration of drugs from day 1 to day 7 | Day 1 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours, Day 5 12 hours, Day 6 0, 12 hours, Day 7 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Genetic polymorphisms of CYP2C9 and CYP3A4 | Exploratory evaluation | Day 1 0 hour |
| Hepatic safety marker of miRNA-122 | Exploratory safety evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital Clinical Trial Center | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Day 1 0 hour, Day 5 12 hour, Day 7 12 hour |
| Safety and tolerability evaluation by monitoring adverse events (number of subjects and cases) | Safety and tolerability evaluation | Day 1 to Day 12 |
| Physical examination (list of current medications) | Safety and tolerability evaluation | Day 1 to Day 12 |
| Physical examination (list of any symptoms or pain) | Safety and tolerability evaluation | Day 1 to Day 12 |
| Physical examination (Medical and surgical history) | Safety and tolerability evaluation | Day 1 to Day 12 |
| Evaluation of Vital signs (body temperature °C) | Safety and tolerability evaluation | Day 1 to Day 12 |
| Evaluation of Vital signs (blood pressure mmHg) | Safety and tolerability evaluation | Day 1 to Day 12 |
| Evaluation of Vital signs (pulse (heart rate, beats per minute)) | Safety and tolerability evaluation | Day 1 to Day 12 |
| Evaluation of Vital signs (breathing rate (respiratory rate, beats per minute)) | Safety and tolerability evaluation | Day 1 to Day 12 |
| Safety and tolerability evaluation by 12-lead ECG (P wave, PR interval, QRS complex, J-point, ST segment, T wave, Corrected QT interval, U wave) | Safety and tolerability evaluation | Day 1 to Day 12 |
| number of participants with abnormal laboratory values (hematologic, chemical, urine) | Safety and tolerability evaluation | Day 1 to Day 12 |