[Translation] A randomized, open-label, fasting single-dose, crossover bioequivalence trial of tiotropium bromide and olodaterol inhalation spray in healthy adult subjects in China
主要研究目的:考察空腹状态下单次经口吸入受试制剂噻托溴铵奥达特罗吸入喷雾剂与参比制剂噻托溴铵奥达特罗吸入喷雾剂,在中国健康人体的相对生物利用度,比较两制剂药代动力学特征,评估两制剂的生物等效性。
次要研究目的:评价空腹状态下使用受试制剂和参比制剂在中国成年健康受试者中的安全性。
[Translation] Main research purpose: To investigate the relative biological effects of a single oral inhalation of the test preparation tiotropium bromide olodaterol inhalation spray and the reference preparation tiotropium bromide olodaterol inhalation spray in healthy human subjects in China under a fasting state. Utilization, compare the pharmacokinetic characteristics of the two preparations, and evaluate the bioequivalence of the two preparations.
Secondary study objectives: To evaluate the safety of test and reference preparations in Chinese adult healthy subjects under fasting conditions.