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学科主题临床医学
Safety and Pharmacokinetic Studies of Silodosin, a New alpha(1A)-Adrenoceptor Selective Antagonist, in Healthy Chinese Male Subjects
Zhou, Ying1; Sun, Pei-Hong1; Liu, Yu-Wang1; Zhao, Xia1; Meng, Lei2; Cui, Yi-Min1
关键词silodosin safety adverse event pharmacokinetics Chinese male subject
刊名BIOLOGICAL & PHARMACEUTICAL BULLETIN
2011-08-01
34期:8页:1240-1245
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Pharmacology & Pharmacy
资助者Daiichi Sankyo Pharmaceuticals (Beijing) Co., Ltd. ; Daiichi Sankyo Pharmaceuticals (Beijing) Co., Ltd.
研究领域[WOS]Pharmacology & Pharmacy
关键词[WOS]BENIGN PROSTATIC HYPERPLASIA ; BLOOD-PRESSURE ; RAT MODEL ; KMD-3213
英文摘要

The objectives of the study were to assess the safety and pharmacokinetics of silodosin capsules in 82 healthy male Chinese subjects. To evaluate the safety after single-dosing escalation, 40 subjects were equally divided into 4 groups (2, 4, 8, 12 mg) by a randomized, double-blind and placebo-controlled design. To assess the pharmacokinetics after single-dosing, 30 subjects were equally divided into 3 groups (4, 8, 12 mg). To assess the safety and pharmacokinetics via multiple-dosing, 12 subjects were included as a group (4 mg once daily at day 1 and day 7; 4 mg twice daily at day 2 through day 6). The safety observations showed that mild adverse events, including postural hypotension, dizziness, and headache, were observed. After single-dosing at doses of 4, 8, and 12 mg, the mean area under the concentration-time curve from 0 to 36 h (AUC(0-36)) values were 136.82 +/- 46.38, 270.17 +/- 54.66, and 474.63 +/- 108.50 mu g/l.h and the mean maximal silodosin concentration in plasma (C-max) values were 26.70 +/- 7.48,48.47 +/- 12.35, and 94.07 +/- 22.59 mu g/l, respectively. After multiple-dosing, the C-max value at day 7 was 33.84 +/- 19.54 mu g/l, and the AUC(0-24) value at day 7 was 193.19 +/- 68.96 mu g/l.h. The accumulation ratio of the AUC value was 1.55 by comparing the multiple-dosing with the single-dosing. It is concluded that silodosin is safe and tolerated in healthy Chinese male subjects at the dosing levels used in this study. The mean C-max and AUC values of silodosin increased proportionally with dose escalation, showing characteristics of linear pharmacokinetics.

语种英语
资助者Daiichi Sankyo Pharmaceuticals (Beijing) Co., Ltd. ; Daiichi Sankyo Pharmaceuticals (Beijing) Co., Ltd.
WOS记录号WOS:000294513000016
引用统计
被引频次:8[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/400002259/59575
专题北京大学第一临床医学院_药剂科
作者单位1.Peking Univ, Hosp 1, Dept Pharm, Base Clin Trial, Beijing 100034, Peoples R China
2.Peking Univ, Hosp 1, Dept Cardiol, Beijing 100034, Peoples R China
推荐引用方式
GB/T 7714
Zhou, Ying,Sun, Pei-Hong,Liu, Yu-Wang,et al. Safety and Pharmacokinetic Studies of Silodosin, a New alpha(1A)-Adrenoceptor Selective Antagonist, in Healthy Chinese Male Subjects[J]. BIOLOGICAL & PHARMACEUTICAL BULLETIN,2011,34(8):1240-1245.
APA Zhou, Ying,Sun, Pei-Hong,Liu, Yu-Wang,Zhao, Xia,Meng, Lei,&Cui, Yi-Min.(2011).Safety and Pharmacokinetic Studies of Silodosin, a New alpha(1A)-Adrenoceptor Selective Antagonist, in Healthy Chinese Male Subjects.BIOLOGICAL & PHARMACEUTICAL BULLETIN,34(8),1240-1245.
MLA Zhou, Ying,et al."Safety and Pharmacokinetic Studies of Silodosin, a New alpha(1A)-Adrenoceptor Selective Antagonist, in Healthy Chinese Male Subjects".BIOLOGICAL & PHARMACEUTICAL BULLETIN 34.8(2011):1240-1245.
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