Pharmacokinetics of indacaterol and mometasone furoate delivered alone or in a free or fixed dose combination in healthy subjects

茚达特罗 糠酸莫米松 医学 交叉研究 药代动力学 皮质类固醇 药理学 最大值 内科学 麻醉 哮喘 支气管扩张剂 安慰剂 病理 替代医学
作者
Soniya Vaidya,Sanjeev Khindri,Nicole Calder,Surendra Machineni,Hisanori Hara,Tapan Majumdar,Salvatore Febbraro,Rainard Fuhr,Ralph Woessner
出处
期刊:Pulmonary Pharmacology & Therapeutics [Elsevier BV]
卷期号:37: 30-36 被引量:14
标识
DOI:10.1016/j.pupt.2016.01.004
摘要

QMF149 is a fixed-dose combination of the long-acting β2 agonist, indacaterol and the corticosteroid, mometasone furoate that is currently under development for treatment of patients with asthma and chronic obstructive pulmonary disease. We describe here a study designed to assess any pharmacokinetic (PK) and/or biopharmaceutical interaction between indacaterol and mometasone furoate when administered via the Breezhaler(®) device, either alone or in a free or fixed combination (QMF149) in healthy adult subjects.In this randomized, open-label, four-way crossover study, subjects were randomized to receive indacaterol acetate 150 μg, mometasone furoate 320 μg, alone and as free combination of the individual components, or QMF149 (indacaterol acetate 150 μg/mometasone furoate 320 μg) once daily for 14 days in each period, followed by a 7-day washout between periods. PK profiles were characterized on Day 14 up to 168 h post-dose.Indacaterol AUC0-24h,ss and Cmax,ss after administration of QMF149 were 13% [ratio: 1.13; 90%CI: 1.09, 1.17] and 18% [ratio: 1.18; 90%CI: 1.12, 1.25] higher, respectively, than indacaterol monotherapy. Mometasone furoate AUC0-24h,ss and Cmax,ss after administration of QMF149 were 14% [ratio: 1.14; 90%CI: 1.09, 1.20] and 19% [ratio: 1.19; 90%CI: 1.13, 1.26], higher, respectively than mometasone furoate monotherapy. The majority (three of four comparisons between QMF149 and monotherapy) of the 90% confidence intervals of the between-treatment ratios for AUC0-24h,ss and Cmax,ss were within the 0.80 to 1.25 interval and therefore fulfilled bioequivalence criteria. The 90% confidence interval for Cmax,ss for MF for the QMF149 vs. monotherapy comparison was [1.13, 1.26]. Although no definitive data can be provided on the basis of the present study results, it is unlikely that the small observed differences in expsoure are clinically meaningful. Multiple inhaled doses of indacaterol and mometasone furoate, when administered alone, in free combination or as QMF149 were well tolerated.The QMF149 fixed dose combination treatment showed comparable systemic exposure to the free combination and monotherapy treatments in terms of AUC0-24h,ss and Cmax,ss for both indacaterol and mometasone furoate, indicating an absence of clinically relevant PK or biopharmaceutical interactions. These data support further development of QMF149 without dose adjustment.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
sunyanghu369发布了新的文献求助10
刚刚
1秒前
清蒸可达鸭完成签到,获得积分10
1秒前
锥子完成签到,获得积分10
1秒前
白色的风车发布了新的文献求助200
1秒前
机会啊完成签到,获得积分10
2秒前
123456完成签到,获得积分10
2秒前
迷路的鸽子完成签到,获得积分10
2秒前
苹果王子6699完成签到 ,获得积分10
3秒前
hani完成签到,获得积分10
4秒前
5秒前
激动的xx关注了科研通微信公众号
5秒前
6秒前
柠檬发布了新的文献求助10
7秒前
夸克的诗意完成签到,获得积分10
7秒前
无花果应助yy湫采纳,获得10
7秒前
7秒前
xlj完成签到,获得积分10
7秒前
清欢完成签到,获得积分10
7秒前
土土完成签到,获得积分10
8秒前
滕遥完成签到,获得积分10
8秒前
木木完成签到,获得积分10
9秒前
Oz完成签到,获得积分10
9秒前
迷人耗子精完成签到,获得积分10
9秒前
Shark完成签到,获得积分10
9秒前
Hello应助leo采纳,获得10
10秒前
沙力VAN完成签到,获得积分10
10秒前
gelinhao完成签到,获得积分10
10秒前
正经大善人完成签到,获得积分10
10秒前
CR7应助zhuww采纳,获得20
11秒前
11秒前
12秒前
赖建琛完成签到 ,获得积分10
12秒前
一叶知秋完成签到 ,获得积分10
12秒前
龙傲天完成签到,获得积分10
13秒前
liii完成签到,获得积分10
13秒前
醒不来的猫完成签到,获得积分10
14秒前
搜集达人应助夸克的诗意采纳,获得10
14秒前
解语花应助土土采纳,获得30
14秒前
刘博士完成签到,获得积分10
15秒前
高分求助中
【提示信息,请勿应助】关于scihub 10000
A new approach to the extrapolation of accelerated life test data 1000
Coking simulation aids on-stream time 450
北师大毕业论文 基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 390
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
Robot-supported joining of reinforcement textiles with one-sided sewing heads 360
Novel Preparation of Chitin Nanocrystals by H2SO4 and H3PO4 Hydrolysis Followed by High-Pressure Water Jet Treatments 300
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 4015859
求助须知:如何正确求助?哪些是违规求助? 3555835
关于积分的说明 11318981
捐赠科研通 3288954
什么是DOI,文献DOI怎么找? 1812355
邀请新用户注册赠送积分活动 887882
科研通“疑难数据库(出版商)”最低求助积分说明 812027