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学科主题: 临床医学
题名:
Tolerability and pharmacokinetics of antofloxacin hydrochloride after multiple oral dose administration in healthy Chinese male volunteers
作者: Xiao, Y.; Lu, Y.; Kang, Z.; Hou, F.; Wang, S.; Li, T.; Liu, Y.; Xia, Y.
关键词: antofloxacin hydrochloride ; multiple dose ; pharmacokinetics ; tolerability ; healthy ; Chinese male volunteers ; serum ; urine
刊名: INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
发表日期: 2008-04-01
卷: 46, 期:4, 页:172-179
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Pharmacology & Pharmacy
研究领域[WOS]: Pharmacology & Pharmacy
英文摘要:

Objective: To evaluate the tolerability and pharmacokinetics characteristics of antofloxacin hydrochloride, a fluoroquinolone developed in China, after multiple oral doses in healthy male Chinese volunteers. Methods: 13 subjects took 300 mg of antofloxacin hydrochloride once daily for 7 days. Safety was evaluated on Days 0, 2, 4 and 8. Blood and urine samples for pharmacokinetics analysis were taken at designated time points. HPLC was used to assay the serum and urine concentration of antofloxacin. Results: A total of 12 subjects completed the trial and 1 volunteer was dropped because of a skin rash 2 h after the drug was administered. 1 volunteer had a prolonged prothrombin time (PT), another had a serum alanine aminotransferase (ALT) elevation and a third had increases in aspartate aminotransferase (AST) and gamma-glutamyltransferase (gamma-GT). No other complaints were reported during the trial. The steady state serum concentration on a daily 300 mg oral dose was obtained at 96 h. The pharmacokinetics parameters at steady state were: t(max) 1.19 +/- 0.59 h, C-max 4.49 +/- 0.81 mg/1, C-min 1.35 +/- 0.33 mg/1, AUC(ss) 74.74 +/- 12.58 mg/1 x h, C-av 3.11 +/- 0.52 mg/1, t(1/2 beta) 20.75 +/- 2.93 h, PTF 102.13 +/- 23.92%. The urinary elimination of antofloxacin over 120 h after the last dose was approximately 62%. C-max in steady state was 50% higher compared to data for Day 1 after a single dose administration. Conclusions: The results indicated that 300 mg antofloxacin hydrochloride once daily oral administration is safe, but can lead to high drug concentrations. This should be evaluated further.

语种: 英语
WOS记录号: WOS:000255069200003
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/55847
Appears in Collections:北京大学第一临床医学院_临床药理研究所_期刊论文

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作者单位: Peking Univ, First Hosp, Inst Clin Pharmacol, Beijing 100871, Peoples R China

Recommended Citation:
Xiao, Y.,Lu, Y.,Kang, Z.,et al. Tolerability and pharmacokinetics of antofloxacin hydrochloride after multiple oral dose administration in healthy Chinese male volunteers[J]. INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS,2008,46(4):172-179.
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