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Pharmacokinetics of Single and Repeat Doses of Fluticasone Furoate/Umeclidinium/Vilanterol in Healthy Chinese Adults.
- Source :
-
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2019 Aug; Vol. 8 (6), pp. 721-733. Date of Electronic Publication: 2018 Nov 14. - Publication Year :
- 2019
-
Abstract
- The 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 (C <subscript>max</subscript> ) and area under the plasma concentration-time curve (AUC) from time zero (predose) to last time of quantifiable concentration (AUC <subscript>0-t</subscript> ). Terminal phase half-life (t <subscript>½</subscript> ) 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 t <subscript>½</subscript> of UMEC and VI was 0.36 and 0.52 hours, respectively; t <subscript>½</subscript> of FF was not representative because of nonquantifiable concentration data. On days 1 and 7, geometric mean C <subscript>max</subscript> of FF was 10.46 and 27.32 pg/mL, respectively; C <subscript>max</subscript> of UMEC was 144.14 and 241.35 pg/mL, respectively; and C <subscript>max</subscript> of VI was 120.42 and 196.78 pg/mL, respectively. AUC <subscript>0-t</subscript> of FF was 1.77 and 276.96 pg·h/mL, respectively; AUC <subscript>0-t</subscript> of UMEC was 28.44 and 117.19 pg·h/mL, respectively; and AUC <subscript>0-t</subscript> 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.<br /> (© 2018, The American College of Clinical Pharmacology.)
- Subjects :
- Administration, Inhalation
Adult
Area Under Curve
Benzyl Alcohols administration & dosage
China
Chlorobenzenes administration & dosage
Double-Blind Method
Drug Administration Schedule
Drug Combinations
Female
Fluticasone administration & dosage
Healthy Volunteers
Humans
Male
Quinuclidines administration & dosage
Young Adult
Benzyl Alcohols pharmacokinetics
Chlorobenzenes pharmacokinetics
Fluticasone pharmacokinetics
Quinuclidines pharmacokinetics
Subjects
Details
- Language :
- English
- ISSN :
- 2160-7648
- Volume :
- 8
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Clinical pharmacology in drug development
- Publication Type :
- Academic Journal
- Accession number :
- 30427594
- Full Text :
- https://doi.org/10.1002/cpdd.626