盐酸阿夫唑嗪分散片在健康人体的生物等效性及安全性评价  

Bioequivalence and safety evaluation of alfuzosin hydrochloride dispersed tablets in healthy volunteers

作　　者：邱枫[1] 孙亚欣[1] 何晓静[1] 肇丽梅[1] 

机构地区：[1]中国医科大学附属盛京医院药学部,沈阳110004

出　　处：《中国临床药理学杂志》2014年第5期425-428,共4页The Chinese Journal of Clinical Pharmacology

基　　金：国家"重大新药创制"科技重大专项十二五基金资助项目(2012ZX09303015)

摘　　要：目的研究中国健康受试者单次口服盐酸阿夫唑嗪分散片和片剂的药代动力学行为并评价2种药物间的生物等效性。方法随机交叉,单次试验设计。24名健康男性受试者口服受试和参比药物各5 mg,测定给药前和给药后24 h内的血药浓度,用DAS软件计算药代动力学参数。结果 24名健康受试者口服受试药物和参比药物后,血浆中阿夫唑嗪的主要药代动力学参数如下,t1/2分别为(4.7±1.7),(5.5±1.6)h,cmax分别为(23.1±7.0),(24.3±8.7)ng·mL-1,AUC0-t分别为(127.0±34.0),(136.8±41.9)ng·h·mL-1;受试药物的相对生物利用度(98.6±32.1)%。结论阿夫唑嗪2种药物间体内生物作用等效。Objective To study pharmacokinetic behaviors of Chinese healthy volunteers after single oral dose alfuzosin hydrochloride dispersed tablet and alfuzosin hydrochloride tablets, and to evaluate the bioequiva- lenee of two different preparations of alfuzosin. Methods This was a randomized, crossover and single - trial design. Twenty - four volunteers were orally administrated with single dose of test and reference prepara- tions of alfuzosin （each 5 mg）. Plasma concentrations within 24 hours were determined before and after administration. Results The main pharmacokinetic parameters of alfuzosin after oral administration were as follows： tl/2 were（4. 7 ±1.7）, （5.5 ±1.6）h, Cmax were（23. 1±7.0）, （24.3 ± 8.71） ng · mL-1, and AUC0-t were （127.0 ±34.0）, （136. 8 ±41.9）ng · h · mL-l, respectively. The relative bioavailability of test formulation was （98.6 ± 32. 1 ） %. Conclusion The two prepa- rations of alfuzosin were bioequivalent.

关 键 词：阿夫唑嗪 分散片 生物等效性 安全性评价 

分 类 号：R971.9[医药卫生—药品] R969.1[医药卫生—药学]