[Translation] A single-center, randomized, open-label, single-dose, two-period, double-crossover clinical study of fluticasone propionate nebulized inhalation suspension in Chinese healthy subjects
主要研究目的:以GlaxoSmithKline Australia Pty Ltd.的丙酸氟替卡松雾化吸入用混悬液(辅舒酮,FLIXOTIDE NEBULES)为参比制剂,以杭州知兴制药有限公司研发的丙酸氟替卡松雾化吸入用混悬液为受试制剂,通过单中心、随机、开放、单次给药、两周期、双交叉临床研究,评价两种制剂在空腹状态下的人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to use the fluticasone propionate suspension for nebulized inhalation (FLIXOTIDE NEBULES) of GlaxoSmithKline Australia Pty Ltd. as the reference preparation and the fluticasone propionate suspension for nebulized inhalation developed by Hangzhou Zhixing Pharmaceutical Co., Ltd. as the test preparation. Through a single-center, randomized, open, single-dose, two-period, double-crossover clinical study, the bioequivalence of the two preparations in the fasting state is evaluated.
Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.