%0 Electronic Article
%A Li, Yan and Li, Huafang and Sheng, Yucheng and Du, Xin and Yao, Yuhui and Luo, Xian and Ma, Peiming
%I Wiley
%D 2019
%D 2019
%G English
%@ 2160-763X
%@ 2160-7648
%~ Katalog UB TU-Chemnitz
%T Pharmacokinetics of Single and Repeat Doses of Fluticasone Furoate/Umeclidinium/Vilanterol in Healthy Chinese Adults
%V 8
%J Clinical Pharmacology in Drug Development
%V 8
%N 6
%P 721-733
%U http://dx.doi.org/10.1002/cpdd.626
%X AbstractThe pharmacokinetics (PK) and safety of single‐inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) after single and repeat dosing in healthy Chinese adults were assessed. In this open‐label study (NCT02837380), subjects received once‐daily FF/UMEC/VI 100/62.5/25 µg on day 1 and repeat doses on days 2–7. PK parameters (days 1 and 7) included maximum observed concentration (Cmax) and area under the plasma concentration‐time curve (AUC) from time zero (predose) to last time of quantifiable concentration (AUC0–t). Terminal phase half‐life (t½) on day 1 was estimated. The primary objective was to assess systemic exposure of FF 100 µg, UMEC 62.5 µg, and VI 25 µg following single‐inhaler triple therapy on days 1 and 7. On day 1, geometric mean t½ of UMEC and VI was 0.36 and 0.52 hours, respectively; t½ of FF was not representative because of nonquantifiable concentration data. On days 1 and 7, geometric mean Cmax of FF was 10.46 and 27.32 pg/mL, respectively; Cmax of UMEC was 144.14 and 241.35 pg/mL, respectively; and Cmax of VI was 120.42 and 196.78 pg/mL, respectively. AUC0–t of FF was 1.77 and 276.96 pg·h/mL, respectively; AUC0–t of UMEC was 28.44 and 117.19 pg·h/mL, respectively; and AUC0–t of VI, 42.46 and 101.12 pg·h/mL, respectively. The PK of FF/UMEC/VI was as expected for the individual‐component PK previously reported in healthy Chinese adults. No new safety signals were observed.
%Z https://katalog.bibliothek.tu-chemnitz.de/Record/ai-49-aHR0cDovL2R4LmRvaS5vcmcvMTAuMTAwMi9jcGRkLjYyNg
%U https://katalog.bibliothek.tu-chemnitz.de/Record/ai-49-aHR0cDovL2R4LmRvaS5vcmcvMTAuMTAwMi9jcGRkLjYyNg