The Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide 400 μg Administered by Inhalation as Single and Multiple (Twice Daily) Doses in Healthy Chinese Participants

• Published in: International Journal of Chronic Obstructive Pulmonary Disease
• Main Authors: Li,Weimin, Daoud,Sami, Trivedi,Roopa, Lukka,Pradeep, Jimenez,Eulalia, Molins,Eduard, Stewart,Catherine, Bharali,Pranob, Garcia-Gil,Esther
• Format: Article in Journal/Newspaper
• Language: English
• Published: Dove Press 2023
• Subjects: International Journal of Chronic Obstructive Pulmonary Disease; sami
• Online Access: https://www.dovepress.com/the-pharmacokinetics-safety-and-tolerability-of-aclidinium-bromide-400-peer-reviewed-fulltext-article-COPD

Weimin Li,1 Sami Z Daoud,2 Roopa Trivedi,3 Pradeep B Lukka,4 Eulalia Jimenez,5 Eduard Molins,5 Catherine Stewart,6 Pranob Bharali,3,7 Esther Garcia-Gil8 1Clinical Trial Center, West China Hospital of Sichuan University, Chengdu, Sichuan Province, People’s Republic of China; 2Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA; 3Late Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Durham, NC, USA; 4Clinical & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gaithersburg, MD, USA; 5Clinical & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Barcelona, Spain; 6Statistics, Phastar, Chiswick, London, UK; 7BioPharmaceuticals R&D Late-Stage Development, AstraZeneca India Pvt Ltd., Bangalore, Karnataka, India; 8Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Barcelona, SpainCorrespondence: Sami Z Daoud, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, One MedImmune Way, Gaithersburg, MD, 20878, USA, Tel [phone], Email [e-mail]: To date, aclidinium pharmacokinetic (PK) studies have focused on Caucasian populations, and no data are available for Chinese populations. We aimed to characterize the PK and safety profile of aclidinium and its metabolites (LAS34823 and LAS34850) following single and multiple (twice-daily; BID) dosing in healthy Chinese participants, and to compare PK data between Chinese and Caucasian populations.Materials and methods: In this Phase I, open-label study (NCT03276052), healthy participants from a single site in China received aclidinium bromide 400 μg via a dry powder inhaler. The Day 1 single dose was followed by a washout period of 96 hours. On Days 5 through 8, participants received BID doses.Results: Twenty healthy Chinese participants, aged 18– 45 years, were enrolled. Aclidinium absorption was rapid (median time to maximum concentration [tmax] ...