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Article(id=1291339261131874722, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291339070622396983, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.03.018, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1722096000000, receivedDateStr=2024-07-28, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785808871776, onlineDateStr=2026-08-04, pubDate=1739721600000, pubDateStr=2025-02-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785808871776, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785808871776, creator=13041195026, updateTime=1785808871776, updator=13041195026, issue=Issue{id=1291339070622396983, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='3', pageStart='301', pageEnd='450', issueExtLink='null', onlineDate='null', pubDate='1739721600000', pubDateStr='2025-02-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785808826353, creator='13041195026', updateTime=1785808826353, updator='13041195026', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=387, endPage=392, ext={EN=ArticleExt(id=1291339261362561443, articleId=1291339261131874722, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Pharmacokinetics/pharmacodynamic study of delafloxacin in Chinese healthy subjects, columnId=1246531407389020354, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Pharmacokinetics and Bioequivalence Study, runingTitle=null, highlight=null, articleAbstract=
Objective

To evaluate the pharmacokinetic characteristics and safety of delafloxacin, a new fluoroquinolone drug, in Chinese healthy subjects, and to evaluate the expected microbiological efficacy of delafloxacin in treating infections caused by Staphylococcus aureus and Streptococcus pneumoniae through pharmacokinetic/pharmacodynamic analysis.

Methods

This trial consists of two parts. The first part is a randomized, double-blind, placebo-controlled, single-dose/multiple-dose administration trial with a dose range of 150-450 mg. The second part is a randomized, open-label, double-period, self-crossover trial comparing the pharmacokinetic similarities between a 300 mg intravenous infusion of the test drug and the reference drug. Combined with the in vitro pharmacodynamic data of delafloxacin against Staphylococcus aureus and Streptococcus pneumoniae clinically isolated in China, the Monte Carlo simulation method was used to analyze the probability of target attainment and cumulative fraction of response of the 300 mg q12 h intravenous infusion over 60 min and to evaluate the expected microbiological efficacy.

Results

After administering 150, 300 and 450 mg of delafloxacin to Chinese healthy subjects in single doses, the Cmax, AUC0-t and AUC0-∞ increase proportionally with the dose. The apparent volume of distribution ranged from 45.79 to 144.38 L. The elimination half-life of each dose group ranged from 2.99 to 11.87 h. The cumulative urinary excretion rates of (47.69±8.11)% and (73.71±9.32)% were observed for single doses of 300 and 450 mg, respectively, suggesting that the primary route of excretion was renal. The 90% confidence interval of Cmax, AUC0-t and AUC0-∞ of test drug over reference drug after single-dose intravenous infusion are all within 80.00%-125.00%. After reaching steady state with multiple-dose administration in the 300 mg group, the plasma exposure level was similar to that of the single-dose administration group.

Conclusion

Single-dose intravenous infusion of 150-450 mg delafloxacin in healthy subjects showed linear pharmacokinetic characteristics, and there was no accumulation after 300 mg q12 h administration. Adverse effects were mild, indicating good safety, and good microbiological efficacy.

, authors=Xu ZHU1, Xing-chen BIAN1, Ji-cheng YU1, Jing-jing WANG1, Hai-jing YANG1, Guo-ying CAO1, Xiao-jie WU1, Jing ZHANG1, Yu-zhu CHEN2, Chun-lin LU2, Jing-an XUAN3, authorsList=Xu ZHU, Xing-chen BIAN, Ji-cheng YU, Jing-jing WANG, Hai-jing YANG, Guo-ying CAO, Xiao-jie WU, Jing ZHANG, Yu-zhu CHEN, Chun-lin LU, Jing-an XUAN, authorCompany=null, correspAuthors=Jing-an XUAN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291339261811351972, articleId=1291339261131874722, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=德拉沙星在中国健康受试者中药代动力学/药效学研究, columnId=1246531407988805834, journalTitle=中国临床药理学杂志, columnName=药代动力学与生物等效性研究, runingTitle=null, highlight=null, articleAbstract=
目的

评价氟喹诺酮类新药德拉沙星在中国健康受试者中药代动力学特征以及安全性，并通过药代动力学/药效学分析评价德拉沙星治疗金黄色葡萄球菌和肺炎链球菌所致感染的预期微生物学疗效。

方法

本试验分为2部分，第1部分为随机、双盲、安慰剂对照、单剂、多剂给药试验，给药剂量为150~450 mg，第2部分为随机、开放、双周期、自身交叉对照试验，比较静脉输注受试制剂和参比制剂300 mg的药代动力学相似性。结合德拉沙星对中国临床分离金黄色葡萄球菌和肺炎链球菌的体外药效学数据，以蒙特卡罗模拟法分析300 mg q12 h静脉输注60 min给药方案的达标概率及累积响应百分率，评价该方案的预期微生物学疗效。

结果

单剂给予中国健康成年受试者国产注射用德拉沙星150、300和450 mg后，Cmax、AUC0-t和AUC0-∞随剂量成比例增加，表观分布容积高达45.79~144.38 L，各剂量组消除半衰期不等，在2.99~11.87 h。72 h内德拉沙星300和450 mg单剂给药累积尿排出率分别达到（47.69±8.11）%和（73.71±9.32）%，提示肾为主要排泄途径。德拉沙星受试制剂与参比制剂单剂静脉输注给药后的Cmax、AUC0-t和AUC0-∞比值的90%置信区间均在80.00%~125.00%。300 mg组多剂给药达稳态后，血浆暴露水平与单剂给药组相近。

结论

健康受试者单剂静脉输注德拉沙星150~450 mg呈线性药代动力学特征，300 mg q12 h给药无蓄积，受试者药物不良反应轻微，安全性好，且可以获得良好的微生物学疗效。

, authors=朱旭1, 卞星晨1, 郁继诚1, 王晶晶1, 杨海静1, 曹国英1, 武晓捷1, 张菁1, 陈昱竹2, 卢春林2, 宣景安3, authorsList=朱旭, 卞星晨, 郁继诚, 王晶晶, 杨海静, 曹国英, 武晓捷, 张菁, 陈昱竹, 卢春林, 宣景安, authorCompany=null, correspAuthors=宣景安, authorNote=

朱旭（1993-），男，护师，主要从事新药Ⅰ期临床研究的相关工作

, correspAuthorsNote=
宣景安，高级工程师 Tel: （0523）86975050 E-mail:
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朱旭（1993-），男，护师，主要从事新药Ⅰ期临床研究的相关工作

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德拉沙星在中国健康受试者中药代动力学/药效学研究
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朱旭 1 , 卞星晨 1 , 郁继诚 1 , 王晶晶 1 , 杨海静 1 , 曹国英 1 , 武晓捷 1 , 张菁 1 , 陈昱竹 2 , 卢春林 2 , 宣景安 3
中国临床药理学杂志 | 药代动力学与生物等效性研究 2025,41(3): 387-392
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中国临床药理学杂志 |药代动力学与生物等效性研究 2025 , 41 (3) : 387 -392
德拉沙星在中国健康受试者中药代动力学/药效学研究
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朱旭1, 卞星晨1, 郁继诚1, 王晶晶1, 杨海静1, 曹国英1, 武晓捷1, 张菁1, 陈昱竹2, 卢春林2, 宣景安3
作者信息
  • 1.复旦大学 附属华山医院 临床药理研究中心，上海 200040
  • 2.扬子江药业集团有限公司 药物研究院临床中心，上海 201203
  • 3.扬子江药业集团有限公司 克服递药屏障高端制剂全国重点实验室，江苏 泰州 225321
通讯作者:
宣景安，高级工程师 Tel: （0523）86975050 E-mail:
作者简介:

朱旭（1993-），男，护师，主要从事新药Ⅰ期临床研究的相关工作

Pharmacokinetics/pharmacodynamic study of delafloxacin in Chinese healthy subjects
Xu ZHU1, Xing-chen BIAN1, Ji-cheng YU1, Jing-jing WANG1, Hai-jing YANG1, Guo-ying CAO1, Xiao-jie WU1, Jing ZHANG1, Yu-zhu CHEN2, Chun-lin LU2, Jing-an XUAN3
Affiliations
  • 1.Clinical Pharmacology Research Center, Huashan Hospital, Fudan University, Shanghai 200040, China
  • 2.Clinical Center of The Pharmaceutical Research Institute, Yangtze River Pharmaceutical Group Co., Ltd., Shanghai 201203, China
  • 3.National Key Laboratory of Complex Drug Formulations for Overcoming Delivery Barriers, Yangtze River Pharmaceutical Group Co., Ltd., Taizhou 225321, Jiangsu Province, China
出版时间: 2025-02-17 doi: 10.13699/j.cnki.1001-6821.2025.03.018
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摘要
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目的

评价氟喹诺酮类新药德拉沙星在中国健康受试者中药代动力学特征以及安全性，并通过药代动力学/药效学分析评价德拉沙星治疗金黄色葡萄球菌和肺炎链球菌所致感染的预期微生物学疗效。

方法

本试验分为2部分，第1部分为随机、双盲、安慰剂对照、单剂、多剂给药试验，给药剂量为150~450 mg，第2部分为随机、开放、双周期、自身交叉对照试验，比较静脉输注受试制剂和参比制剂300 mg的药代动力学相似性。结合德拉沙星对中国临床分离金黄色葡萄球菌和肺炎链球菌的体外药效学数据，以蒙特卡罗模拟法分析300 mg q12 h静脉输注60 min给药方案的达标概率及累积响应百分率，评价该方案的预期微生物学疗效。

结果

单剂给予中国健康成年受试者国产注射用德拉沙星150、300和450 mg后，Cmax、AUC0-t和AUC0-∞随剂量成比例增加，表观分布容积高达45.79~144.38 L，各剂量组消除半衰期不等，在2.99~11.87 h。72 h内德拉沙星300和450 mg单剂给药累积尿排出率分别达到（47.69±8.11）%和（73.71±9.32）%，提示肾为主要排泄途径。德拉沙星受试制剂与参比制剂单剂静脉输注给药后的Cmax、AUC0-t和AUC0-∞比值的90%置信区间均在80.00%~125.00%。300 mg组多剂给药达稳态后，血浆暴露水平与单剂给药组相近。

结论

健康受试者单剂静脉输注德拉沙星150~450 mg呈线性药代动力学特征，300 mg q12 h给药无蓄积，受试者药物不良反应轻微，安全性好，且可以获得良好的微生物学疗效。

德拉沙星  /  抗菌药物  /  药代动力学/药效学  /  安全性
Objective

To evaluate the pharmacokinetic characteristics and safety of delafloxacin, a new fluoroquinolone drug, in Chinese healthy subjects, and to evaluate the expected microbiological efficacy of delafloxacin in treating infections caused by Staphylococcus aureus and Streptococcus pneumoniae through pharmacokinetic/pharmacodynamic analysis.

Methods

This trial consists of two parts. The first part is a randomized, double-blind, placebo-controlled, single-dose/multiple-dose administration trial with a dose range of 150-450 mg. The second part is a randomized, open-label, double-period, self-crossover trial comparing the pharmacokinetic similarities between a 300 mg intravenous infusion of the test drug and the reference drug. Combined with the in vitro pharmacodynamic data of delafloxacin against Staphylococcus aureus and Streptococcus pneumoniae clinically isolated in China, the Monte Carlo simulation method was used to analyze the probability of target attainment and cumulative fraction of response of the 300 mg q12 h intravenous infusion over 60 min and to evaluate the expected microbiological efficacy.

Results

After administering 150, 300 and 450 mg of delafloxacin to Chinese healthy subjects in single doses, the Cmax, AUC0-t and AUC0-∞ increase proportionally with the dose. The apparent volume of distribution ranged from 45.79 to 144.38 L. The elimination half-life of each dose group ranged from 2.99 to 11.87 h. The cumulative urinary excretion rates of (47.69±8.11)% and (73.71±9.32)% were observed for single doses of 300 and 450 mg, respectively, suggesting that the primary route of excretion was renal. The 90% confidence interval of Cmax, AUC0-t and AUC0-∞ of test drug over reference drug after single-dose intravenous infusion are all within 80.00%-125.00%. After reaching steady state with multiple-dose administration in the 300 mg group, the plasma exposure level was similar to that of the single-dose administration group.

Conclusion

Single-dose intravenous infusion of 150-450 mg delafloxacin in healthy subjects showed linear pharmacokinetic characteristics, and there was no accumulation after 300 mg q12 h administration. Adverse effects were mild, indicating good safety, and good microbiological efficacy.

delafloxacin  /  antibacterial drug  /  pharmacokinetics/pharmacodynamics  /  safety
朱旭, 卞星晨, 郁继诚, 王晶晶, 杨海静, 曹国英, 武晓捷, 张菁, 陈昱竹, 卢春林, 宣景安. 德拉沙星在中国健康受试者中药代动力学/药效学研究. 中国临床药理学杂志, 2025 , 41 (3) : 387 -392 . DOI: 10.13699/j.cnki.1001-6821.2025.03.018
Xu ZHU, Xing-chen BIAN, Ji-cheng YU, Jing-jing WANG, Hai-jing YANG, Guo-ying CAO, Xiao-jie WU, Jing ZHANG, Yu-zhu CHEN, Chun-lin LU, Jing-an XUAN. Pharmacokinetics/pharmacodynamic study of delafloxacin in Chinese healthy subjects[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (3) : 387 -392 . DOI: 10.13699/j.cnki.1001-6821.2025.03.018
基金
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  • 国家自然科学基金面上基金资助项目(82173896)
  • 上海申康医院发展中心研究型医师创新转化能力培训基金资助项目(SHDC2022CRS004B)
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2025年第41卷第3期
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doi: 10.13699/j.cnki.1001-6821.2025.03.018
  • 接收时间：2024-07-28
  • 首发时间：2026-08-04
  • 出版时间：2025-02-17
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  • 收稿日期：2024-07-28
基金
国家自然科学基金面上基金资助项目(82173896)
上海申康医院发展中心研究型医师创新转化能力培训基金资助项目(SHDC2022CRS004B)
作者信息
    1.复旦大学 附属华山医院 临床药理研究中心，上海 200040
    2.扬子江药业集团有限公司 药物研究院临床中心，上海 201203
    3.扬子江药业集团有限公司 克服递药屏障高端制剂全国重点实验室，江苏 泰州 225321

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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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