中国临床药理学杂志2012，Vol.28Issue(10)：755-757,3.
赛洛多辛胶囊在健康中国男性的生物等效性
Bioequivalence of silodosin capsules in Chinese healthy male subjects
许俊羽 1崔一民 1赵侠 1张捷 2李晓娇 2顾景凯 2王梓凝 1周颖 1梁雁 1孟磊1
作者信息
- 1. 北京大学 第一医院 药剂科,北京100034
- 2. 吉林大学 药物代谢研究中心,长春130023
- 折叠
摘要
Abstract
Objective To evaluate the bioequivalence of the two silodosin capsules in Chinese healthy subjects. Methods A single oral dose 4 mg of test and reference silodosin capsules were given to 32 subjects according to an open randomized crossover design. The concentrations of silodosin in plasma were determined by LC - MS/MS. The pharmacokinet-ic parameters were calculated and the bioequivalence was compared by non - compartment model of WinNonlin program. Results The main pharma-cokinetic parameters of silodosin of the test and reference preparations were as follows:Cmax were (28. 14 ± 10. 12), (29.43 ± 10.28) ng ? mL-1 ;tmax were (0.98 ±0.65), (1.06 ±0.76)h;t1/2 were (7.27 ± 1.75), (7.50 ± 1.42) h; AUC0-24h were (120.22 ±35.08), (114.59 ±31.24) ng ? H ? mL-1. The 90% confidential interval of Cmax, AUC0-24h and AUC0-∞ of tested formulation were 85.6% - 106.0% ,97.5% - 111. 6% and 97.2% -110.9%. The relative bioavailability of silodosin of test preparations was (106. 7 ±22. 2)%. Conclusion The two preparations were bioequivalent.关键词
赛洛多辛/液相色谱-串联质谱法/生物等效性Key words
silodosin/ LC - MS/MS/ bioequivalence分类
医药卫生引用本文复制引用
许俊羽,崔一民,赵侠,张捷,李晓娇,顾景凯,王梓凝,周颖,梁雁,孟磊..赛洛多辛胶囊在健康中国男性的生物等效性[J].中国临床药理学杂志,2012,28(10):755-757,3.
