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Short-term Safety, Tolerability, and Pharmacokinetics of MRX-I, an Oxazolidinone Antibacterial Agent, in Healthy Chinese Subjects 期刊论文

编号：

a463573b-6655-498f-a515-52d107e37c02
作者：

Wu, Xiaojie^[1,2];Li, Yunfei^[1,2];Zhang, Jing^[1,2];Zhang, Yingyuan(张婴元)^[1,2]Yu, Jicheng^[1,2];Cao, Guoying^[1,2];Chen, Yuancheng^[1,2];Guo, Beining(郭蓓宁)^[1,2]Shi, Yaoguo^[1,2];Huang, Jun^[1,2];Cao, Yuran^[1,2];Liu, Xiaofang^[1,2];Wu, Jufang(吴菊芳)^[1,2]Gordeev, Mikhail Fedorovich^[3];Yuan, Hong^[3];Wang, Wen^[3];
语种：

英文
期刊：

CLINICAL THERAPEUTICS ISSN：0149-2918 2018 年 40 卷 2 期 (322 - 332) ; FEB
收录：
关键词：

healthy subjects MRX-I pharmacokinetics safety
摘要：

Purpose: This study was designed to evaluate the safety and pharmacokinetic profiles of MRX-I tablet, an oxazolidinone antibacterial agent, in healthy Chinese subjects.
Methods: The study was composed of 3 sequential periods. Period 1 was a randomized, double-blind, placebo-controlled, sequential ascending dose (50 to 1800 mg) study. Period 2 included one arm as a randomized, open-label, 3-period, 3 x 3 Latin square single-dose study of 300, 600, and 900 mg MRX-I administration and another arm as a crossover study to evaluate high-fat diet effect. Period 3 was a randomized, double-blind, placebo-controlled multiple-dose study with 600 or 800 mg, q12h regimens over 15 days.
Findings: MRX-I was rapidly absorbed and reached peak plasma concentration at about 2 hours post dose. The C-max was 8.07, 12.24, and 15.25 mg/L and the corresponding AUC(0-infinity) 29.21, 48.27, and 59.60 mg/h/L, in 300-, 600-, and 900-mg dosing groups, respectively. High-fat diet increased the exposure of MRX-I. No discernable drug accumulation was observed after 15 days of continuous drug administration. About 2% of MRX-I was excreted via kidneys in unchanged form. No obvious hematologic toxicity by MRX-I was observed during the entire study. Based on Monte Carlo simulation, 600 or 800 mg BID can produce satisfactory efficacy against methicillin-resistant Staphylococcus aureus. (C) 2018 Elsevier HS Journals, Inc. All rights reserved.
推荐引用方式
GB/T 7714：

Wu Xiaojie,Li Yunfei,Zhang Jing, et al. Short-term Safety, Tolerability, and Pharmacokinetics of MRX-I, an Oxazolidinone Antibacterial Agent, in Healthy Chinese Subjects [J].CLINICAL THERAPEUTICS,2018,40(2):322-332.
APA：

Wu Xiaojie,Li Yunfei,Zhang Jing,Zhang Yingyuan,&Wang Wen.(2018).Short-term Safety, Tolerability, and Pharmacokinetics of MRX-I, an Oxazolidinone Antibacterial Agent, in Healthy Chinese Subjects .CLINICAL THERAPEUTICS,40(2):322-332.
MLA：

Wu Xiaojie, et al. "Short-term Safety, Tolerability, and Pharmacokinetics of MRX-I, an Oxazolidinone Antibacterial Agent, in Healthy Chinese Subjects" .CLINICAL THERAPEUTICS 40,2(2018):322-332.
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