/ CompletedNot Applicable 噻托溴铵吸入粉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、两制剂、两周期交叉的生物等效性试验
[Translation] A randomized, open-label, single-dose, two-formulation, two-period crossover bioequivalence study of tiotropium bromide inhalation powder 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噻托溴铵吸入粉雾剂[规格：18μg（按噻托铵计，相当于噻托溴铵水合物22.5μg）]与参比制剂噻托溴铵吸入粉雾剂[商品名：思力华®，规格：18μg（按噻托铵计，相当于噻托溴铵水合物22.5μg）]，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] The main purpose of the study is to investigate the relative bioavailability of a single oral inhalation of the test preparation tiotropium bromide inhalation powder [specification: 18μg (based on tiotropium, equivalent to 22.5μg tiotropium bromide hydrate)] and the reference preparation tiotropium bromide inhalation powder [trade name: Spiriva®, specification: 18μg (based on tiotropium, equivalent to 22.5μg tiotropium bromide hydrate)] in healthy Chinese subjects in the fasting state, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations.
Secondary purpose of the study: to evaluate the safety of the test preparation and the reference preparation in healthy Chinese adult subjects in the fasting state.
/ CompletedNot Applicable 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.
/ CompletedNot Applicable 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.
100 Clinical Results associated with Aitme (Suzhou) Medical Technology Co., Ltd.
0 Patents (Medical) associated with Aitme (Suzhou) Medical Technology Co., Ltd.
100 Deals associated with Aitme (Suzhou) Medical Technology Co., Ltd.
100 Translational Medicine associated with Aitme (Suzhou) Medical Technology Co., Ltd.
