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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
11
To be determined mg of Voriconazole (Vfend®, anti-fungal agent)
Seoul National University Hospital Clinical Trial Center
Seoul, South Korea
Peak plasma concentration (Cmax)
Pharmacokinetic sampling after administration of drugs from day 1 to day 7
Time frame: 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
Time frame: 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
Genetic polymorphisms of CYP2C9 and CYP3A4
Exploratory evaluation
Time frame: Day 1 0 hour
Hepatic safety marker of miRNA-122
Exploratory safety evaluation
Time frame: 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
Time frame: Day 1 to Day 12
Physical examination (list of current medications)
Safety and tolerability evaluation
Time frame: Day 1 to Day 12
Physical examination (list of any symptoms or pain)
Safety and tolerability evaluation
Time frame: Day 1 to Day 12
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Physical examination (Medical and surgical history)
Safety and tolerability evaluation
Time frame: Day 1 to Day 12
Evaluation of Vital signs (body temperature °C)
Safety and tolerability evaluation
Time frame: Day 1 to Day 12
Evaluation of Vital signs (blood pressure mmHg)
Safety and tolerability evaluation
Time frame: Day 1 to Day 12
Evaluation of Vital signs (pulse (heart rate, beats per minute))
Safety and tolerability evaluation
Time frame: Day 1 to Day 12
Evaluation of Vital signs (breathing rate (respiratory rate, beats per minute))
Safety and tolerability evaluation
Time frame: 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
Time frame: Day 1 to Day 12
number of participants with abnormal laboratory values (hematologic, chemical, urine)
Safety and tolerability evaluation
Time frame: Day 1 to Day 12