/ Not yet recruitingNot Applicable STXA吸入喷雾剂在健康受试者中的单剂量、随机、开放、两制剂、交叉生物等效性试验
[Translation] A single-dose, randomized, open-label, two-dose, crossover bioequivalence study of STXA inhalation spray in healthy subjects
以中国健康受试者为试验对象,采用自身交叉对照的试验设计,以STXA吸入喷雾剂为受试制剂(T),以原研厂家生产的STXA吸入喷雾剂为参比制剂(R),考察受试制剂的相对生物利用度,评价制剂间的生物等效性,并观察STXA吸入喷雾剂在中国健康受试者中的安全性。
[Translation] Chinese healthy subjects were used as test subjects, and a self-crossover control trial design was adopted. STXA inhalation spray was used as the test preparation (T), and STXA inhalation spray produced by the original research manufacturer was used as the reference preparation (R). The relative bioavailability of the test preparation was investigated, the bioequivalence between the preparations was evaluated, and the safety of STXA inhalation spray in Chinese healthy subjects was observed.
/ CompletedNot Applicable STXA喷雾剂在健康受试者中的单剂量、随机、开放、两制剂、交叉生物等效性预试验
[Translation] A single-dose, randomized, open-label, two-formulation, crossover bioequivalence pilot study of STXA spray in healthy subjects
本研究目的是以中国健康受试者为试验对象,采用自身交叉对照的试验设计,以天津药业研究院股份有限公司提供的STXA雾剂(2.5 μg/揿)为受试制剂(T),以原研厂家生产的STXA吸入喷雾剂(2.5 μg/揿)为参比制剂(R),考察受试制剂的相对生物利用度,评价制剂间的生物等效性,并观察噻托溴铵喷雾剂在中国健康受试者中的安全性。
[Translation] The purpose of this study was to use Chinese healthy subjects as test subjects, adopt a self-crossover experimental design, use STXA spray (2.5 μg/press) provided by Tianjin Pharmaceutical Research Institute Co., Ltd. as the test preparation (T), and use STXA inhalation spray (2.5 μg/press) produced by the original manufacturer as the reference preparation (R), to investigate the relative bioavailability of the test preparation, evaluate the bioequivalence between preparations, and observe the safety of tiotropium bromide spray in Chinese healthy subjects.
100 Clinical Results associated with Jinyao Biotechnology (Tianjin) Co., Ltd.
0 Patents (Medical) associated with Jinyao Biotechnology (Tianjin) Co., Ltd.
100 Deals associated with Jinyao Biotechnology (Tianjin) Co., Ltd.
100 Translational Medicine associated with Jinyao Biotechnology (Tianjin) Co., Ltd.