中国临床药理学杂志2024，Vol.40Issue(4)：598-602,5.DOI:10.13699/j.cnki.1001-6821.2024.04.025
度洛西汀在中国健康受试者中的群体药代动力学研究
Population pharmacokinetics of duloxetine in Chinese healthy subjects
摘要
Abstract
Objective To establish a population pharmacokinetic(PPK)model of duloxetine in Chinese subjects.Methods Based on the data of intensive sampling of duloxetine hydrochloride enteric coated tablets in 36 healthy subjects after single/multiple administrations,a PPK model of duloxetine was established using NONMEM software.The effects of gender,age,body weight,albumin,serum creatinine,glutamic pyruvic transaminase and dose on pharmacokinetic parameters were investigated by stepwise forward and backward methods.Model validation includes goodness of fit,visual prediction check and bootstrap.Results The PPK model of duloxetine was a one compartment model with first-order elimination and the absorption characteristics were described by the transit model,and the dose was a covariate of clearance.The inter-individual variability of clearance,volume of distribution,mean transit time and number of transit compartments were 54.71％,56.86％,27.30％and 87.71％,respectively.Conclusion The transit model more reasonably describes the absorption characteristics of duloxetine in Chinese subjects.关键词
度洛西汀/转移室模型/群体药代动力学/吸收Key words
duloxetine/transit model/population pharmacokinetics/absorption分类
医药卫生引用本文复制引用
黄志伟,王蕊,余一旻,李妍,沈一峰,李华芳,魏宇梅..度洛西汀在中国健康受试者中的群体药代动力学研究[J].中国临床药理学杂志,2024,40(4):598-602,5.基金项目
上海申康医院发展中心医企融合创新支撑技能培训专项基金资助项目(SHDC2022CRS032) （SHDC2022CRS032）
上海转化医学协同创新中心课题基金资助项目(TM202116PT) （TM202116PT）
上海市"科技创新行动计划"生物医药科技支撑专项基金资助项目(22S21902300) （22S21902300）
