噻托溴铵吸入喷雾剂在中国成年健康受试者中的一项随机、开放、空腹单次给药、交叉的生物等效性试验
[Translation] A randomized, open-label, fasting single-dose, crossover bioequivalence study of tiotropium bromide inhalation spray in healthy Chinese adult subjects
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吸入喷雾剂与参比制剂噻托溴铵吸入喷雾剂,在中国健康人体的相对生物利用度,分析两种制剂的药代动力学参数,评价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 study objectives: To investigate the relative bioavailability of a single oral inhalation of the test preparation tiotropium bromide inhalation spray and the reference preparation tiotropium bromide inhalation spray in healthy Chinese subjects under fasting conditions, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations.
Secondary study objectives: To evaluate the safety of the test preparation and the reference preparation in healthy Chinese adult subjects under fasting conditions.
噻托溴铵奥达特罗吸入喷雾剂在中国成年健康受试者中的一项随机、开放、空腹单次给药、交叉生物等效性试验
[Translation] A randomized, open-label, fasting single-dose, crossover bioequivalence study of tiotropium bromide and olodaterol inhalation spray in healthy Chinese adult subjects
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] The main purpose of the study is to investigate the relative bioavailability 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 Chinese subjects under fasting conditions, to compare the pharmacokinetic characteristics of the two preparations, and to evaluate the bioequivalence of the two preparations.
Secondary purpose of the study is to evaluate the safety of the test preparation and the reference preparation in healthy Chinese adult subjects under fasting conditions.
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