Pharmacokinetics of indacaterol, glycopyrronium and mometasone furoate administered as an inhaled fixed-dose combination in Japanese and Caucasian healthy subjects.
Background: A once-daily (o.d.) fixed-dose combination of indacaterol acetate (IND), glycopyrronium bromide (GLY), and mometasone furoate (MF) delivered via the Breezhaler® device (IND/GLY/MF) is being developed for treatment of asthma. This study compared steady-state pharmacokinetics of IND, GLY a...
| Publicado en: | BMC Pulmonary Medicine Vol. 21; no. 1; pp. 1 - 13 |
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| Autores principales: | , , , , , , |
| Formato: | clinical trial research tables/charts Journal Article |
| Publicado: |
BioMed Central
1/7/2021
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=147996629&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 147996629 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 14712466 1CIL jtl: BMC Pulmonary Medicine issn: 14712466 maglogo: N pubinfo: dt: 1/7/2021 vid: 21 iid: 1 pid: 24147 pub: BioMed Central artinfo: ui: 147996629 147996629 NLM33413291 147996629 10.1186/s12890-020-01382-6 NLM33413291 147996629 ppf: 1 ppct: 12 formats: tig: atl: Pharmacokinetics of indacaterol, glycopyrronium and mometasone furoate administered as an inhaled fixed-dose combination in Japanese and Caucasian healthy subjects. aug: au: Inoue, Satoru Vaidya, Soniya Tillmann, Hanns-Christian Sakita, Yohei Machineni, Surendra Heudi, Olivier Furihata, Kenichi affil: Novartis Pharma KK, Tokyo, Japan sug: subj: Bronchodilator Agents Pharmacokinetics Antiinfective Agents, Quinolone Pharmacokinetics Glycopyrrolate Pharmacokinetics Hydrocarbons Pharmacokinetics Asians Crossover Design Female Research Subjects Drug Combinations Bronchodilator Agents Administration and Dosage Male Human Glycopyrrolate Administration and Dosage Antiinfective Agents, Quinolone Administration and Dosage Young Adult Hydrocarbons Administration and Dosage Adult Administration, Inhalation Clinical Trials Comparative Studies Multicenter Studies Evaluation Research Validation Studies Adult: 19-44 years Female Male ab: Background: A once-daily (o.d.) fixed-dose combination of indacaterol acetate (IND), glycopyrronium bromide (GLY), and mometasone furoate (MF) delivered via the Breezhaler® device (IND/GLY/MF) is being developed for treatment of asthma. This study compared steady-state pharmacokinetics of IND, GLY and MF between Japanese and Caucasian male subjects after multiple inhalations of IND/GLY/MF o.d.Methods: This was a single-center, open-label, 2-treatment crossover study with a 21-day washout period. Japanese and Caucasian subjects received IND/GLY/MF 150/50/80 μg (inhaled corticosteroid [ICS] medium-dose) or 150/50/160 μg o.d. (ICS high-dose) for 14 days in each period. Pharmacokinetics were characterized up to 24 h post-dose on Days 1 and 14.Results: In total, 16 Japanese (median age 31 years [range 20-40 years], mean weight 68.3 kg) and 17 Caucasian subjects (median age 27 years [range 21-43 years], mean weight 75.0 kg) were randomized. Geometric mean ratios (Japanese/Caucasian) [90% confidence interval (CI)] for Cmax for IND, GLY and MF at the high ICS dose on Day 14 were 1.31 [1.13, 1.51] 1.38 [1.13, 1.69] and 1.07 [0.969, 1.18], respectively. Geometric mean ratios (Japanese/Caucasian) [90% CI] for AUC0-24h on Day 14 for IND, GLY and MF at the high ICS dose were 1.17 [1.01, 1.35], 1.05 [0.920, 1.20] and 1.15 [1.05, 1.27] respectively. Similar trends were noted for all components for the medium ICS dose treatment. IND/GLY/MF was safe and well tolerated; no AEs suspected to be study drug-related were observed.Conclusion: Pharmacokinetics of IND, GLY and MF (high and medium dose) when delivered as a fixed-dose combination were comparable between Japanese and Caucasian subjects. The IND/GLY/MF combination at the administrated doses was safe and well tolerated in both ethnic groups.Trial Registration: Japan Registry of Clinical Trial: jRCT2031200227, retrospectively registered on 04, December, 2020. pubtype: Academic Journal doctype: clinical trial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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