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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABCD | Experimental | Group1: 0.5mg/kg Group2: 1.0mg/kg Group3: 1.5mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABCD | Drug | Intravenous infusion of dexamethasone 5mg before ABCD intravenous administration; Single infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of single infusion of ABCD | Peak Plasma Concentration,. | 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 | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Zhang, Ph.D | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34686365 | Derived | Huang ZW, Yu JC, Wang JJ, Chen YC, Wu JF, Chen YJ, Cao GY, Yang HJ, He JJ, Dai JY, Zhang JY, Zhang W, Yuan J, Li CL, Xu FY, Wang K, Wu XJ, Zhang J. Pharmacokinetics and Safety of Single-Dose Amphotericin B Colloidal Dispersion in Healthy Chinese Subjects and Population Pharmacokinetic/Pharmacodynamic Analysis to Inform Clinical Efficacy in Invasive Infections Caused by Candida albicans. Clin Ther. 2021 Nov;43(11):1921-1933.e7. doi: 10.1016/j.clinthera.2021.09.012. Epub 2021 Oct 20. |
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| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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