Shanghai New Yellow River Pharmaceutical Co Ltd.

To evaluate the pharmacokinetics of budesonide, formoterol, and umeclidinium after single and repeated inhalation of CP006 inhalation powder in healthy subjects. To evaluate the safety and tolerability of CP006 inhalation powder after single and repeated inhalation.

This study aims to evaluate the pharmacokinetic parameters of CP006 inhalation powder (specification: 195μg/5.5μg/27.5μg) produced by Shanghai New Yellow River Pharmaceutical Co., Ltd. under the condition of fasting inhalation administration. The pharmacokinetic characteristics of this product (two inhalations at a time) are compared with control preparation 1 (umeclidinium inhalation powder, specification: 62.5μg, one inhalation at a time), control preparation 2 Symbicort® Turbuhaler® (budesonide and formoterol inhalation powder (II), specification: 160μg/4.5μg, four inhalations at a time), and control preparation 1 + control preparation 2 under the same dose of single administration.

Using budesonide formoterol inhalation powder (II) (Symbicort® Turbuhaler®) produced by AstraZeneca AB as a positive control drug, the efficacy of budesonide formoterol inhalation powder (II) produced by Shanghai New Yellow River Pharmaceutical Co., Ltd. in the treatment of adult bronchial asthma was evaluated as non-inferior to the positive control drug. The safety of budesonide formoterol inhalation powder (II) in the treatment of adult bronchial asthma was evaluated.