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富马酸酮替芬分散片在健康人体的药动学及生物等效性评价
http://www.100md.com 《第四军医大学学报》 2004年第18期
富马酸酮替芬,,富马酸酮替芬;色谱法,液相;光谱分析,质理;药代动力学;生物利用度,0引言,1材料和方法,2结果,3讨论,【参考文献】
     Assessment of pharmacokiretics and bioequivalnce of ketotifen fnmarate in healthy volunteers

    CHEN XiaoLi, WEN AiDong, ZHAO Lei, WANG Men, WU Yin, LI HongLi

    Department of Pharmacentics, Xijing Hospital , Fourth Military Medical University, Xian 710033, China

    【Abstract】 AIM: To investigate the pharmacokinetics and bioequivalence of ketotifen fumarate in healthy volunteers. METHODS: A single oral dose of the tested and control ketotifen fumarate was given respectively to 12 healthy volunteers in a randomized twoperiod crossover study. The serum concentration of the two drugs was determined at different time points within 36 hours following the administration by liquid chromatographicmass spectrometric. The main pharmacokinetics parameters were calculated and the bioequivalence was evaluated by two oneside t test and 90% confidence intervals. RESULTS: The main pharmacokinetics parameters were tmax: (2.7±1.2) and (3.1±1.4)h, cmax: (407±147)and(389±168)ng/L, t1/2:(5.5±1.6)and(5.7±2.6)h, and AUC:(2900±1043)and(2763±977)ng/(h·L). The relative bioavailability of the tested drug was (112±39)%. CONCLUSION: Compared with the control, tested ketotifen fumarate has the advantages of faster absorption and higher bioavailability. The results of statistical analysis indicate that the two drugs are bioequivalent in healthy volunteers (P<0.05). ......

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