对乙酰氨基酚干混悬剂在健康人体内的药动学和生物等效性研究
Pharmacokinetics and bioequivalence of paracetamol suspension in Chinese healthy volunteers
郭伟一 1冯仕银 1蔡林芮 1邹琴 1陈卓 1苏旭 1杜丹 1余勤1
作者信息
- 1. 四川大学华西第二医院国家药物临床试验机构,成都 610041;四川大学华西第二医院药物制剂体内外相关性技术研究重点实验室,成都 610041;四川大学华西第二医院出生缺陷与相关妇儿疾病教育部重点实验室,成都 610041
- 折叠
摘要
目的:评价健康受试者空腹和餐后条件下单次口服对乙酰氨基酚干混悬剂受试制剂和参比制剂的生物等效性.方法:空腹/餐后各26 例健康受试者口服受试制剂对乙酰氨基酚干混悬剂和参比制剂对乙酰氨基酚细粒剂(CALONAL®Fine Gran),采用单次口服、单中心、随机、开放、双周期、交叉设计,用HPLC-MS/MS法检测血浆中对乙酰氨基酚浓度,使用Phoenix WinNonlin 8.1 软件及SAS 9.4 软件分析生物等效性(BE).结果:空腹组26 例健康受试者分别单次空腹服用对乙酰氨基酚干混悬剂(受试制剂)和对乙酰氨基酚细粒剂(参比制剂)后,Cmax,AUC0～t及 AUC0～∞的几何均数比值及其 90%置信区间分别为 100.72%(90.88%,111.63%),96.55%(92.80%,100.46%),95.58%(92.78%,98.48%),均落在等效区间 80.0%～125.00%范围内.餐后组26 例健康受试者在餐后口服对乙酰氨基酚干混悬剂(受试制剂)和对乙酰氨基酚细粒剂(参比制剂)后,Cmax,AUC0～t及AUC0～∞的几何均数比值及其90%置信区间分别为96.69%(89.52%,104.43%),98.27%(95.63%,100.98%),98.59%(96.01%,101.24%),均落在等效区间80.0%～125.00%范围内.结论:2 种制剂在空腹和餐后条件下具有生物等效性.
Abstract
Objective:To evaluate the bioequivalence between a single test and reference dose of Paracetamol Suspension in healthy volunteers under the fasting and fed conditions.Methods:A randomized,open label,single-dose,self-crossover design was performed.HPLC-MS/MS was applied to detect the concentrations of acetamidophenol in the plasma of healthy subjects under the fasting and fed conditions.Phoenix WinNonlin 8.1 and SAS 9.4 software were used for PK parameters calculation and bioequivalence analysis.Results:Under the fasting condition,13 healthy subjects were administered by test and 13 by reference preparation.The ratio of the geometric mean and 90%confidence interval of Cmax,AUC0～t and AUC0～∞ are 100.72%(90.88%,111.63%),96.55%(92.80%,100.46%),95.58%(92.78%,98.48%),respectively.All the data fell within the equivalent range of 80.0%～125.00%.Under the fed condition,13 healthy subjects were administered by test and 13 by reference preparation.The ratio of the geometric mean and 90%confidence interval of Cmax,AUC0～t and AUC0～∞are 96.69%(89.52%,104.43%),98.27%(95.63%,100.98%),98.59%(96.01%,101.24%).All the data fell within the equivalent range of 80.0%～125.00%.Conclusion:The two preparations are bioequivalent under fasting and fed conditions.
关键词
对乙酰氨基酚干混悬剂/空腹/餐后/生物等效性/药动学Key words
acetamidophenol suspension/fasting/fed/bioequivalence/pharmacokinetics引用本文复制引用
出版年
2024
NETL
NSTL
维普
万方数据