布瓦西坦片在健康受试者中的生物等效性研究
Bioequivalence of Brivaracetam Tablets in healthy subjects
徐满 1秦月雯 1赖健明 1曾洁萍 2程玲1
作者信息
- 1. 江西青峰药业有限公司,江西 赣州 341000
- 2. 成都中医药大学附属医院,四川 成都 610000
- 折叠
摘要
目的 研究布瓦西坦片在空腹和餐后给药状态下的生物等效性.方法 采用单中心、单剂量、随机、开放、两周期、交叉试验设计,空腹和餐后组 28 例受试者最终入组,分别单次给予布瓦西坦片受试制剂或参比制剂 50 mg即 1 片,用 240 mL温水送服.采用HPLC-MS/MS法测定人血浆样本中布瓦西坦,使用Phoenix WinNonlin 8.1 软件计算药动学参数,SAS 9.4 软件进行统计分析.结果 布瓦西坦片两种制剂的主要药动学参数(AUC0-∞、AUC0-t和Cmax)几何均值均在生物等效性80.00%～125.00%.结论 布瓦西坦受试制剂与参比制剂在健康受试者空腹和餐后给药状态下具有生物等效性.
Abstract
Objective To study the bioequivalence of Brivaracetam Tablets under fasting and fed administration.Methods A single-center,single-dose,randomized,open,two-cycle,cross-over trial was conducted.Twenty-eight subjects in the fasting and fed groups were included.Healthy subjects were po administer with Brivaracetam Tablets test or reference preparation of 50 mg(one tablets)with 240 mL warm water in a single dose.HPLC-MS/MS method was used to determine brivaracetam in human plasma samples.Phoenix WinNonlin 8.1 software was used to calculate pharmacokinetic parameters,and SAS 9.4 software was used for statistical analysis.Results The geometric mean values of main pharmacokinetic parameters(AUC0-∞,AUC0-t,and Cmax)of Brivaracetam Tablets two preparations in the two groups were in the range of 80.00%—125.00%.Conclusion The test preparation and reference preparation of Brivaracetam Tablets are bioequivalent in healthy subjects under fasting or fed condition.
关键词
布瓦西坦片/布瓦西坦/药动学/生物等效性/HPLC-MS/MSKey words
Brivaracetam Tablets/brivaracetam/pharmacokinetics/bioequivalence/HPLC-MS/MS引用本文复制引用
出版年
2024
NETL
NSTL
万方数据