CAJ | 학술논문

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。
목적：연구중국건강수시자단차구복염산아부서진분산편화편제적약대동역학행위병평개2충약물간적생물등효성。방법수궤교차，단차시험설계。24명건강남성수시자구복수시화삼비약물각5 mg，측정급약전화급약후24 h내적혈약농도，용DAS연건계산약대동역학삼수。결과24명건강수시자구복수시약물화삼비약물후，혈장중아부서진적주요약대동역학삼수여하，t1/2분별위（4.7±1.7），（5.5±1.6）h，cmax분별위（23.1±7.0），（24.3±8.7）ng· mL-1， AUC0-t분별위（127.0±34.0），（136.8±41.9）ng· h· mL-1；수시약물적상대생물이용도（98.6±32.1）％。결론아부서진2충약물간체내생물작용등효。
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-lence 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:t1/2 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-1, respectively.The relative bioavailability of test formulation was ( 98.6 ±32.1 )%.Conclusion The two prepa-rations of alfuzosin were bioequivalent.