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A clinical trail to investigate the influence of SLCO2B1 polymorphism on the pharmacokinetic characteristics of voriconazole in CYP2C19 poor metabolizers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLCO2B1 wild type | Experimental | Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h (Day 1) - washout period - Vfend (voriconazole) 200 mg tablet once (Day 8) |
|
| SLCO2B1 variant | Experimental | Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h (Day 1) - washout period - Vfend (voriconazole) 200 mg tablet once (Day 8) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vfend (voriconazole) intravenous infusion | Drug | Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic outcome - Maximum plasma concentration (Cmax) | predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose | |
| Pharmacokinetic outcome - Area under the plasma concentration versus time curve (AUC) | predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SeungHwan Lee, MD., PhD. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital Clinical Trial Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D065819 | Voriconazole |
| D007262 | Infusions, Intravenous |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Vfend (voriconazole) tablet | Drug | Vfend (voriconazole) 200 mg tablet once |
|
|
| D061605 |
| Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007263 | Infusions, Parenteral |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |