[Translation] A single-center, randomized, open-label, fasting single-dose, two-drug, two-sequence, four-cycle crossover biological study of budesonide suspension for inhalation in Chinese adult healthy subjects under the condition of taking activated charcoal and not taking activated charcoal. efficacy test
主要研究目的:考察空腹单次经口吸入受试制剂吸入用布地奈德混悬液(规格:2mL:1mg,艾特美(苏州)医药科技有限公司生产)与参比制剂吸入用布地奈德混悬液(普米克令舒®,规格:2mL:1mg),阿斯利康生产),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: To investigate the budesonide suspension for inhalation of the test preparation (specification: 2mL: 1mg, produced by Aitemei (Suzhou) Pharmaceutical Technology Co., Ltd.) and the budesonide for inhalation of the reference preparation by oral inhalation on an empty stomach. Suspension (Pulmicort Rescue®, specification: 2mL: 1mg, produced by AstraZeneca), the relative bioavailability in Chinese healthy subjects, the comparison of the pharmacokinetic characteristics of the two preparations, and the evaluation of the bioequivalence of the two preparations .
Secondary research purpose: To evaluate the safety of the test preparation and the reference preparation in Chinese adult healthy subjects under fasting conditions.