Seoul National University Hospital Clinical Trial Center
Seoul, 03080, South Korea
NCT Number: NCT03760276
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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Notify Me20 year–45 year
All sexes
Interventional
Phase 1
Seoul, 03080, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
To be determined mg of Voriconazole (Vfend®, anti-fungal agent)
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
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
Pharmacokinetic sampling after administration of drugs from day 1 to day 7
Time frame: Day 1 0 hour
Exploratory evaluation
Time frame: Day 1 0 hour, Day 5 12 hour, Day 7 12 hour
Exploratory safety evaluation
Time frame: Day 1 to Day 12
Safety and tolerability evaluation
Time frame: Day 1 to Day 12
Safety and tolerability evaluation
Time frame: Day 1 to Day 12
Safety and tolerability evaluation
Time frame: Day 1 to Day 12
Safety and tolerability evaluation
Time frame: Day 1 to Day 12
Safety and tolerability evaluation
Time frame: Day 1 to Day 12
Safety and tolerability evaluation
Time frame: Day 1 to Day 12
Safety and tolerability evaluation
Time frame: Day 1 to Day 12
Safety and tolerability evaluation
Time frame: Day 1 to Day 12
Safety and tolerability evaluation
Time frame: Day 1 to Day 12
Safety and tolerability evaluation
Seoul National University Hospital
Other
A Pilot Study 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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