Population pharmacokinetics of duloxetine in Chinese healthy subjects
10.13699/j.cnki.1001-6821.2024.04.025
- VernacularTitle:度洛西汀在中国健康受试者中的群体药代动力学研究
- Author:
Zhi-Wei HUANG
1
;
Rui WANG
;
Yi-Min YU
;
Yan LI
;
Yi-Feng SHEN
;
Hua-Fang LI
;
Yu-Mei WEI
Author Information
1. 上海交通大学医学院附属精神卫生中心临床研究中心,上海 200000
- Keywords:
duloxetine;
transit model;
population pharmacokinetics;
absorption
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(4):598-602
- CountryChina
- Language:Chinese
-
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.
