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Single Dose Escalations Study of Amphotericin B Colloidal Dispersion In Healthy Subjects in China

Invasive Fungal Disease Clinical Trial

Official title:
Pharmacokinetics, Safety and Tolerability of Single Infusion of Amphotericin B Colloidal Dispersion In Healthy Subjects in China

Clinical Trial Summary

The purpose of this trial is to evaluate the pharmacokinetics of single intravenous of Amphotericin B Colloidal Dispersion(ABCD)in Chinese healthy subjects.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03577509
Study type Interventional
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date July 2, 2018
Completion date September 14, 2018
View Details
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