摘要
目的 研究头孢克洛胶囊的相对生物利用度,评价该试验制剂的生物等效性.方法 对20 名男性健康受试者采用随机交叉双周期给药方式,分别口服单剂量参比制剂和头孢克洛试验制剂500 mg,通过反相高效液相色谱法测定血药浓度,计算两者的相对生物利用度和药代动力学参数,评价该制剂的生物等效性.结果 按lnAUC0-t计算,与参比制剂相比,单剂量口服受试药的相对生物利用度为(97.5±10.0)%.试验制剂头孢克洛胶囊和参比制剂头孢克洛胶囊之间lnAUC0-T、lnAUC0-∞经双向单侧t 检验,AUC0-T、AUC0-∞的[1-2α]置信区间在参比制剂相应参数的80%~125%范围内,表明两种制剂在吸收程度具有生物等效性;lnCmax经方差分析和双向单侧t 检验,Cmax的[1-2α]置信区间在参比制剂相应参数的75%~133%范围内,表明两种制剂在吸收的峰值浓度上具有生物等效性;Tmax经非参检验,两制剂间差异无统计学意义,表明两制剂在达峰时间上具有生物等效性.结论 头孢克洛的两种胶囊制剂具有相似的人体药代动力学特点,生物利用度也相同.
Abstract
Objective To study the relative bioavailability of cefaclor capsule in Chinese healthy volunteers and evaluate the bioequivalence. Methods A single oral dose 500 mg of test and reference formulations was given to 20 healthy volunteers in a randomized cross-over study. The concentrations of cefaclor in plasma were determined by HPLC. Results The relative bioavailability of lnAUCo.T was (97.5±10.0)%. Two formulations were bioequiva-lent. The 90% confidence interval of AUC0-T and AUC0=x were in the range of 80-125%; Cmax was in the range of 75~ 133%, so the two tablets were bioequivalent. Conclusion There were similar human pharmacokinetic characteristics and same bioavailability in human subjects between two capsules of cefaclor.
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维普
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