[Translation] A Phase I, open-label, single- and multiple-dose (twice daily) clinical trial to evaluate the pharmacokinetic properties, safety, and tolerability of aclidinium bromide 400 μg by inhalation in healthy Chinese participants
主要目的是评估阿地溴铵 400 μg 制剂在中国健康志愿者中单剂给药和多剂(每日二次)给药后,阿地溴铵及其代谢物的药代动力学(PK)特性。
次要目的是评估阿地溴铵 400 μg 制剂单剂给药和多剂(每日二次)给药在健康中国参与者中的安全性和耐受性。
[Translation] The primary objective was to evaluate the pharmacokinetic (PK) properties of aclidinium bromide and its metabolites after single and multiple (twice daily) doses of aclidinium bromide 400 μg formulation in healthy Chinese volunteers.
The secondary objective was to evaluate the safety and tolerability of aclidinium bromide 400 μg formulation in healthy Chinese participants after single and multiple (twice daily) doses.