卡马西平片在中国健康受试者中的生物等效性研究  

Bioequivalence study of carbamazepine tablets in Chinese healthy subjects

作　　者：李斌 巴艳朋 刘艳杰 李艳娜 李孟媛 朱韶峰 LI Bin;BA Yan-peng;LIU Yan-jie;LI Yan-na;LI Meng-yuan;ZHU Shao-feng(Phase I Clinical Trials Centre,Luoyang Central Hospital Affiliated to Zhengzhou University,Luoyang 471000,Henan Province,China)

机构地区：[1]郑州大学附属洛阳中心医院药物Ⅰ期临床试验研究室,河南洛阳471000

出　　处：《中国临床药理学杂志》2023年第5期718-722,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价卡马西平片在中国健康受试者的生物等效性。方法用单剂量、单中心、随机、开放、四周期自身交叉试验设计。空腹状态下46例、餐后状态下24例健康受试者,随机分为2组,每周期每组单次口服卡马西平受试制剂或参比制剂0.1 g,采用验证的液质联用法(HPLC-MS/MS)测定健康人血浆中卡马西平的浓度,应用Phoenix WinNonlin软件(Pharsight Corporation 7.0版本)进行非房室模型药代动力学参数的估算分析,计算主要药代动力学参数,其余关于描述性与推断性统计分析采用SAS 9.4版本统计软件进行统计分析。结果受试者服用受试制剂和参比制剂后,药代动力学参数如下,空腹组:C_(max)分别为1912.15和1850.11 ng·mL^(-1);AUC_(0-t)分别为80775.69和81884.12 h·ng·mL^(-1)。2种制剂的C_(max)、AUC_(0-t)的几何均值比值相对应的90%置信区间分别为97.76%~100.21%,101.29%~105.89%。餐后组:C_(max)分别为1611.37和1619.17 ng·mL^(-1);AUC_(0-t)分别为77426.90和78070.12 h·ng·mL^(-1)。2种制剂的C_(max)、AUC_(0-t)的几何均值比值相对应的90%置信区间分别为97.74%~101.27%,97.80%~102.16%。结论2种卡马西平片在中国健康受试者体内具有生物等效性。Objective To evaluate the bioequivalence of two kinds of carbamazepine in healthy Chinese subjects.Methods This was a single dose,open,random,four periods,cross design.46 healthy subjects in fasting state and 24 healthy subjects fed state were randomly divided into two groups,oral carbamazepine test preparation or reference preparation0.1 g per group once a cycle.The plasma concentration of carbamazepine in human plasma samples was determined by HPLC-MS/MS,and the pharmacokinetic parameters were calculated by Phoenix Win Nonlin Pharsight Corporation 7.0 software,and the bioequivalence was evaluated by SAS 9.4 software.Results The main pharmacokinetic parameters of test and reference formulation were as follows:the fasting state C_(max)were 1912.15,1850.11 ng·mL^(-1);AUC_(0-t)were 80775.69,81884.12 h·ng·mL^(-1);the 90%confidential interval(CI)of C_(max)and AUC_(0-t)were 97.76%-100.21%,101.29%-105.89%.The fed state C_(max)were 1611.37,1619.17 ng·mL^(-1);AUC_(0-t)were77426.90,78070.12 h·ng·mL^(-1);the 90%CI of C_(max),AUC_(0-t)were 97.74%-101.27%,97.80%-102.16%.Conclusion The two carbamazepine tablets were bioequivalent in Chinese healthy subjects.

关 键 词：卡马西平片 药代动力学 生物等效性 

分 类 号：R971[医药卫生—药品]