[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, four-period, repeated crossover controlled design was used to evaluate the bioequivalence of a single dose of budesonide suspension for inhalation in healthy Chinese subjects in the fasting state.
主要目的:以四川海梦智森生物制药有限公司提供的吸入用布地奈德混悬液为受试制剂;并以AstraZeneca Pty Ltd的吸入用布地奈德混悬液为参比制剂,进行人体相对生物利用度和生物等效性评价。
[Translation] Main objective: To evaluate the relative bioavailability and bioequivalence of budesonide suspension for inhalation provided by Sichuan Haimeng Zhisen Biopharmaceutical Co., Ltd. as the test preparation and budesonide suspension for inhalation provided by AstraZeneca Pty Ltd as the reference preparation.