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
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 volunteersCHEN XiaoLi, WEN AiDong, ZHAO Lei, WANG Men, WU Yin, LI HongLi
Department of Pharmacentics, Xijing Hospital , Fourth Military Medical University, Xian 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 twoperiod crossover study. The serum concentration of the two drugs was determined at different time points within 36 hours following the administration by liquid chromatographicmass spectrometric. The main pharmacokinetics parameters were calculated and the bioequivalence was evaluated by two oneside 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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