[Translation] A single-dose, randomized, development, two-agent, self-crossover design of a single-dose, randomized, developmental, bioequivalence pilot trial of indacaterogronium bromide inhalation powder in healthy subjects
本研究以江西艾施特制药有限公司生产的茚达特罗格隆溴铵吸入粉雾剂为受试制剂(T),以Novartis Pharma Schweiz AG持证的茚达特罗格隆溴铵吸入粉雾剂(商品名:杰润®)为参比制剂(R),初步评价受试制剂(T)和参比制剂(R)在空腹条件下给药的生物等效性,为正式试验给药方式与操作流程、采样量、采血时间点、样本量、给药剂量等设计的合理性提供参考,并同时考察药物在健康受试者体内的安全性。
[Translation] In this study, indacaterogloronium bromide inhalation powder inhalation powder produced by Jiangxi Esther Pharmaceutical Co., Ltd. was used as the test preparation (T), and indacaterogronium bromide inhalation powder certified by Novartis Pharma Schweiz AG was used as the test preparation (T). The aerosol (trade name: Jierun®) is the reference preparation (R), the bioequivalence of the test preparation (T) and the reference preparation (R) under fasting conditions is preliminarily evaluated, and it is administered for the formal test The method and operation process, sampling volume, blood sampling time point, sample volume, administration dose, etc. are designed to provide reference for the rationality of the design, and at the same time, the safety of the drug in healthy subjects is examined.