The purpose of this trial is to evaluate the pharmacokinetics of single intravenous of Amphotericin B Colloidal Dispersion(ABCD)in Chinese healthy subjects.
Primary Objective: Evaluation the pharmacokinetics, safety and tolerability of single intravenous of ABCD in Chinese healthy subjects. Secondary Objective: Evaluation the safety and tolerability of single intravenous of ABCD in Chinese healthy subjects. Exploratory Objective:Evaluation the effect of single intravenous ABCD on early renal injury indicators (KIM-1 and cystatin C) in Chinese healthy subjects.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Intravenous infusion of dexamethasone 5mg before ABCD intravenous administration; Single infusion.
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Pharmacokinetics of single infusion of ABCD
Peak Plasma Concentration,.
Time frame: before infusion and at the midpoint and end of the infusion;and at 15 and 30 min;1,2,4,7,10,24,48,72,120,168,240,336,408,504,576 and 672hour postinfusion
Pharmacokinetics of single infusion of ABCD
Area under the plasma concentration versus time curve
Time frame: before infusion and at the midpoint and end of the infusion;and at 15 and 30 min;1,2,4,7,10,24,48,72,120,168,240,336,408,504,576 and 672hour postinfusion
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