Zhuhai Resproly Biopharmaceutical Co., Ltd.

Main research objectives Preliminary part: Evaluate the pharmacokinetic parameters of the test preparation glycopyrrolate inhalation powder (specification: 50 μg (calculated in C19H28NO3)) and the reference preparation glycopyrrolate inhalation powder (trade name: Seebri® Breezhaler®, specification: 50 μg (calculated in C19H28NO3)) under fasting conditions in healthy subjects, evaluate the differences in formulation and process, verify the analytical method, optimize the sampling time, preliminarily estimate the degree of intra-individual variation in subjects, and obtain other relevant information to provide a basis for the formal test design. Formal test part: Evaluate the pharmacokinetic behavior of the test preparation glycopyrrolate inhalation powder (specification: 50 μg (calculated in C19H28NO3)) developed by Zhuhai Ruisi Puli Pharmaceutical Technology Co., Ltd. and the reference preparation glycopyrrolate inhalation powder (trade name: Seebri® Breezhaler®, specification: 50 μg (calculated in C19H28NO3)), and evaluate the bioequivalence of the two preparations. Secondary study objectives To evaluate the safety of the test preparation glycopyrrolate inhalation powder (specification: 50 μg (calculated as C19H28NO3)) and the reference preparation glycopyrrolate inhalation powder (trade name: Seebri® Breezhaler®, specification: 50 μg (calculated as C19H28NO3)) in healthy people.

Main purpose: To investigate the administration method and operation process of the test preparation budesonide formoterol inhalation powder (II) (produced by Zhuhai Ruisipuli Pharmaceutical Technology Co., Ltd., specifications: 320 μg/9 μg) and the reference preparation budesonide formoterol inhalation powder (II) (produced by AstraZeneca AB, trade name: Symbicort Turbuhaler®/Symbicort Turbuhaler®, specifications: 320 μg/9 μg) under fasting conditions; to investigate the rationality of the settings such as sampling volume and blood collection time point, to verify the plasma drug concentration analysis method, and to provide a basis for formal trials. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Primary objective: To investigate the administration and operation procedures of the test preparation budesonide formoterol inhalation powder (II) (produced by Zhuhai Ruisipuli Pharmaceutical Technology Co., Ltd., specifications: 320 μg/9 μg) and the reference preparation budesonide formoterol inhalation powder (II) (produced by AstraZeneca AB, trade name: Symbicort Turbuhaler®/Symbicort Turbuhaler®, specifications: 320 μg/9 μg) under fasting and activated carbon blocking conditions; to investigate the rationality of the settings such as sampling volume and blood collection time points, to verify the plasma drug concentration analysis method, and to provide a basis for formal trials. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.