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Pharmacokinetics and safety of indacaterol and glycopyrronium (IND/GLY) following repeated once daily inhalation from a fixed-dose combination in healthy Chinese subjects

Ren, Shuang and Sechaud, Romain and Su, Frank and Tillmann, Hanns-Christian and Hara, Hisanori and Tan, Xuemei and Hou, Jie and Woessner, Ralph and Zhao, Rong (2017) Pharmacokinetics and safety of indacaterol and glycopyrronium (IND/GLY) following repeated once daily inhalation from a fixed-dose combination in healthy Chinese subjects. International Journal of Clinical Pharmacology and Therapeutics , 55 (2). pp. 147-155.

Abstract

Objective
Indacaterol/glycopyrronium (IND/GLY) is a once daily fixed-dose combination of two long acting bronchodilators indacaterol 110µg (long acting β2-adrenergic agonist, LABA) and glycopyrronium 50µg (long acting muscarinic antagonist, LAMA). This study assessed the pharmacokinetics of IND/GLY 110/50µg following multiple once-daily inhaled administrations in healthy Chinese subjects.
Methods
This was a single-centre, open-label, multiple-dose study of inhaled IND/GLY delivered via the Breezhaler® device. Pharmacokinetic parameters were determined on Day1 after first dose, on Days 5, 7, 10 and 12 (pre-dose [trough]) and on Day14 (steady-state) after last dose using non-compartmental analysis.
Results
Both IND and GLY were absorbed rapidly after inhalation of IND/GLY (Tmax: IND, 15 min; GLY, 5 min). Accumulation in systemic exposure of both IND and GLY from Day 1 to Day 14 was observed (mean accumulation ratio (Racc) of AUC0-24h (Day 14/Day 1): IND, 3.02; GLY 2.94; estimated accumulation ratio of Cmax: IND 1.56; GLY 1.33). Mean effective half-life (T 1/2,acc) was 41.3h and 40.0h for IND and GLY respectively. Pharmacokinetic steady-states were reached after 12 and 10 days of daily dosing for IND and GLY, respectively. There was one mild AE not related to the study drug. No discontinuations due to treatment related AEs/SAEs were reported.
Conclusions
In healthy Chinese subjects, multiple once-daily inhaled doses of IND/GLY 110/50µg were rapidly absorbed and were safe and well tolerated. The comparison of systemic exposure data following inhalation of IND/GLY 110/50 µg in Chinese versus the non-Chinese population did not indicate any clinically relevant differences across ethnicities and races.

Item Type: Article
Date Deposited: 18 Feb 2017 00:45
Last Modified: 18 Feb 2017 00:45
URI: https://oak.novartis.com/id/eprint/28597

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