摘要
目的研究恩曲他滨分散片在健康志愿者体内的相对生物利用度。方法采用标准二阶段交叉设计（Two-peri-od Crossover Design）自身对照试验方法。血药浓度测定采用高效液相色谱法。结果单次口服200mg恩曲他滨分散片和恩曲他滨胶囊的t1/2分别为4.41±1.66h,4.25±1.75h,Tmax分别为0.77±0.2h、0.94±0.25h,Cmax分别为2345.82±680.61ng.mL-1、2290.47±722.08ng.mL-1,AUC（0~24h）分别为10330.91±3105.55ng.h.mL-1、9751.35±2622.75ng.h.mL-1。试验过程中未观察到药物不良反应发生。结论恩曲他滨分散片对Gilead Science公司生产的Emtriva（恩曲他滨胶囊）的相对生物利用度为105.4%,两种恩曲他滨制剂在人体内具有生物等效性。
OBJECTIVE To study the relative bioavailability of Emtricitabine Dispersible Tablets in healthy volunteers.METHODS An oral dose of 200mg Emtricitabine Dispersible Tablets and 200mg Emtriva were given to twenty healthy volunteers in a Two-period crossover design.The drug concentrations were determined by the HPLC method.RESULTS The main pharmacokinetic parameters were as follows：Tmax were 0.77±0.24h,0.94±0.25h;Cmax were 2345.82±680.61ng·mL-1,2290.47±722.08ng·mL-1;t1/2 were 4.41±1.66h,4.25±1.75h,AUC（0~24h） were 10330.91±3105.55ng·h·mL-1,9751.35±2622.75ng·h·mL-1,respectively.The statistic results showed no significant difference between the above two preparations.CONCLUSION The two preparations were bioequivalent.
出处
《齐鲁药事》
2009年第9期556-558,共3页
qilu pharmaceutical affairs
