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学科主题临床医学
Pharmacokinetics of antofloxacin hydrochloride in healthy male subjects after multiple intravenous dose administration
Wang, J.; Xiao, Y.; Lu, Y.; Kang, Z.; Zhang, M.; Liu, Y.; Liang, J.; Zhang, M.; Li, T.
关键词Antofloxacin hydrochloride multiple-dose pharmacokinetics intravenous healthy male volunteers
刊名XENOBIOTICA
2011-07-01
DOI10.3109/00498254.2011.565820
41期:7页:561-566
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Pharmacology & Pharmacy ; Toxicology
研究领域[WOS]Pharmacology & Pharmacy ; Toxicology
关键词[WOS]CHINESE MALE-VOLUNTEERS ; FLUOROQUINOLONE ; LEVOFLOXACIN ; RATS
英文摘要

The purpose of the study was to evaluate pharmacokinetic characteristics of antofloxacin hydrochloride, a new fluoroquinolone antibiotic, during a multiple, intravenous dosing regimen.

Twelve healthy, Chinese male volunteer subjects were each given 300 mg of antofloxacin by intravenous infusion once daily for 7 days. Blood and urine samples were taken at designated time points for analysis of antofloxacin concentration by high-performance liquid chromatography (HPLC). Safety and tolerability were assessed by evaluation of subject complaints, vital signs, electrocardiograms, electroencephalograms, clinical chemistry parameters, haematology and urinalysis and prothrombin time.

The serum steady concentration of antofloxacin was obtained in 96 h after the administration of a daily intravenous dose of 300 mg of the drug. In the present study, the following pharmacokinetic parameters after 7 days of treatment with antofloxacin were determined to be: C(max) 3.81 +/-+/- 0.66 mg/L, C(min) 0.85 +/-+/- 0.19 mg/L, AUC(0--24) 60.51 +/-+/- 8.30 mg/L center dot center dot h, C(av) 2.52 +/-+/- 0.35 mg/L, PTF 87.45 +/-+/- 3.37%, t(1/2)beta beta 20.34 +/-+/- 1.88 h. The C(max) and AUC(0--24) after 7-day treatment were both higher than after the first dose (by 43% and 110%, respectively). The cumulative urinary elimination of antofloxacin within 96 h after the last dose was about 56%.

During the study, there were neither subject complaints nor significant adverse clinical findings.

Antofloxacin, administered intravenously as a single, daily 300 mg dose for 7 days, demonstrated favourable pharmacokinetic characteristics and tolerability. The results of this study indicate that antofloxacin hydrochloride is suitable for further clinical study.

语种英语
WOS记录号WOS:000291537900005
引用统计
被引频次:1[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/59480
专题北京大学第一临床医学院_临床药理研究所
作者单位Peking Univ, Inst Clin Pharmacol, Hosp 1, Beijing 100191, Peoples R China
推荐引用方式
GB/T 7714
Wang, J.,Xiao, Y.,Lu, Y.,et al. Pharmacokinetics of antofloxacin hydrochloride in healthy male subjects after multiple intravenous dose administration[J]. XENOBIOTICA,2011,41(7):561-566.
APA Wang, J..,Xiao, Y..,Lu, Y..,Kang, Z..,Zhang, M..,...&Li, T..(2011).Pharmacokinetics of antofloxacin hydrochloride in healthy male subjects after multiple intravenous dose administration.XENOBIOTICA,41(7),561-566.
MLA Wang, J.,et al."Pharmacokinetics of antofloxacin hydrochloride in healthy male subjects after multiple intravenous dose administration".XENOBIOTICA 41.7(2011):561-566.
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