[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of ciclesonide inhalation aerosol in healthy subjects under fasting conditions
主要目的:健康受试者空腹状态下,经口吸入给药单剂量环索奈德吸入气雾剂(受试制剂T,上海上药信谊药厂有限公司生产,规格:160μg/揿)与环索奈德吸入气雾剂(参比制剂R,Covis Pharma Gmbh生产,商品名:Alvesco®,规格:160μg/揿)后,本次试验考察空腹条件下受试制剂与参比制剂在人体内的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性。次要目的:观察受试制剂环索奈德吸入气雾剂和参比制剂环索奈德吸入气雾剂(Alvesco®)在健康受试者中的安全性。
[Translation] Primary objective: After oral administration of a single dose of ciclesonide inhalation aerosol (test preparation T, produced by Shanghai SPH Xinyi Pharmaceutical Co., Ltd., specification: 160μg/press) and ciclesonide inhalation aerosol (reference preparation R, produced by Covis Pharma Gmbh, trade name: Alvesco®, specification: 160μg/press) to healthy subjects in the fasting state, this study investigates the absorption rate and extent of the test preparation and the reference preparation in the human body under fasting conditions, and evaluates whether the test preparation and the reference preparation are bioequivalent. Secondary objective: To observe the safety of the test preparation ciclesonide inhalation aerosol and the reference preparation ciclesonide inhalation aerosol (Alvesco®) in healthy subjects.