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学科主题: 临床医学
题名:
Safety and Pharmacokinetic Studies of Silodosin, a New alpha(1A)-Adrenoceptor Selective Antagonist, in Healthy Chinese Male Subjects
作者: 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
发表日期: 2011-08-01
卷: 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
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
项目资助者: Daiichi Sankyo Pharmaceuticals (Beijing) Co., Ltd.
WOS记录号: WOS:000294513000016
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/59575
Appears in Collections:北京大学第一临床医学院_药剂科_期刊论文

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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

Recommended Citation:
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.
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