The aim of this study is to evaluate the effects of food or proton pump inhibitor on the pharmacokinetics of itraconazole in healthy volunteers.
Evaluation criteria * Pharmacokinetic assessment with plasma concentrations of itraconazole and hydroxy-itraconazole * Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, and laboratory tests
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Itraconazole 100 mg capsule x 2
Esomeprazole 40 mg tablet x 1
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Cmax of itraconazole
Pharmacokinetic parameters of itraconazole
Time frame: Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
AUClast of itraconazole
Pharmacokinetic parameters of itraconazole
Time frame: Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
AUCinf of itraconazole
Pharmacokinetic parameters of itraconazole
Time frame: Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
Tmax of itraconazole
Pharmacokinetic parameters of itraconazole
Time frame: Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
t1/2 of itraconazole
Pharmacokinetic parameters of itraconazole
Time frame: Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
CL/F of itraconazole
Pharmacokinetic parameters of itraconazole
Time frame: Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
Vd/F of itraconazole
Pharmacokinetic parameters of itraconazole
Time frame: Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
Cmax of hydroxy-itraconazole
Pharmacokinetic parameters of hydroxy-itraconazole
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Time frame: Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
AUClast of hydroxy-itraconazole
Pharmacokinetic parameters of hydroxy-itraconazole
Time frame: Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
AUCinf of hydroxy-itraconazole
Pharmacokinetic parameters of hydroxy-itraconazole
Time frame: Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
Tmax of hydroxy-itraconazole
Pharmacokinetic parameters of hydroxy-itraconazole
Time frame: Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
t1/2 of hydroxy-itraconazole
Pharmacokinetic parameters of hydroxy-itraconazole
Time frame: Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose
metabolic ratio of hydroxy-itraconazole
Pharmacokinetic parameters of hydroxy-itraconazole
Time frame: Day 1/Day 8/Day 16 pre-dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 hour post-dose