茚达特罗
医学
慢性阻塞性肺病
人口
吸入
毒蕈碱拮抗剂
药代动力学
支气管扩张剂
药理学
麻醉
内科学
敌手
哮喘
环境卫生
受体
作者
Ivan Demin,Christian Bartels,Gordon Graham,Bruno Bieth,Aurélie Gautier,Hanns-Christian Tillmann,Romain Séchaud
出处
期刊:International Journal of Clinical Pharmacology and Therapeutics
[Dustri-Verlag Dr. Karl Feistle]
日期:2016-06-01
卷期号:54 (06): 405-414
被引量:5
摘要
Indacaterol/glycopyrronium (IND/GLY) is a fixed-dose combination (FDC) of indacaterol, an inhaled long-acting β2-agonist (LABA), and glycopyrronium, an inhaled long-acting muscarinic antagonist (LAMA), developed as a maintenance bronchodilator treatment for patients with chronic obstructive pulmonary disease (COPD). A population pharmacokinetic (PK) analysis was performed to describe the PK profiles of indacaterol and glycopyrronium following the twice daily (b.i.d.) and once daily (o.d.) inhalation regimens as FDC or as monotherapies and to determine the effect of covariates.PK data in 556 COPD patients were pooled from three phase 3 studies. Two phase 3 studies investigated IND/GLY 27.5/12.5 μg b.i.d. and the third study investigated IND/GLY 110/50 μg o.d. Body weight was included in the model with fixed allometric coefficients for indacaterol and glycopyrronium.Statistically significant effects of smoking, age, and sex on apparent clearance of indacaterol; smoking, and estimated glomerular filtration rate at baseline on apparent clearance and Japanese ethnicity on apparent central volume of distribution of glycopyrronium were identified.Systemic exposure to indacaterol and glycopyrronium was shown to be dose-proportional and time-independent following inhalation either as monotherapies or FDC. None of the identified covariate effects was judged to be clinically relevant. There is no PK drug-drug interaction between indacaterol and glycopyrronium in its FDC.
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