沙美特罗替卡松吸入粉雾剂在中国成年健康受试者中的一项单中心、随机、开放、空腹单次给药生物等效性试验
[Translation] A single-center, randomized, open-label, fasting single-dose bioequivalence study of salmeterol/fluticasone inhalation powder 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沙美特罗替卡松吸入粉雾剂与参比制剂沙美特罗替卡松吸入粉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 the test preparation salmeterol-fluticasone inhalation powder and the reference preparation salmeterol-fluticasone inhalation powder in healthy Chinese subjects after single oral inhalation in the fasting state, 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 in the fasting state.
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.
吸入用布地奈德混悬液在中国成年健康受试者中的一项单中心、随机、开放、空腹单次给药、两制剂、交叉生物等效性试验
[Translation] A single-center, randomized, open-label, fasting single-dose, two-dose, crossover bioequivalence study of budesonide suspension for inhalation in healthy adult Chinese subjects
主要研究目的：考察空腹状态下单次经口吸入受试制剂吸入用布地奈德混悬液与参比制剂吸入用布地奈德混悬液，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：评价空腹状态下单次经口吸入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 the test preparation budesonide suspension for inhalation and the reference preparation budesonide suspension for inhalation in healthy Chinese subjects after single oral inhalation in the fasting state, to compare the pharmacokinetic characteristics of the two preparations, and to evaluate the bioequivalence of the two preparations.
The secondary purpose of the study is to evaluate the safety of the test preparation and the reference preparation in healthy Chinese adult subjects after single oral inhalation in the fasting state.
100 Clinical Results associated with Aitme (Suzhou) Medical Technology Co., Ltd.
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100 Deals associated with Aitme (Suzhou) Medical Technology Co., Ltd.
100 Translational Medicine associated with Aitme (Suzhou) Medical Technology Co., Ltd.
