Shanghai New Yellow River Pharmaceutical Co Ltd.

Under the condition of fasting inhalation administration, the pharmacokinetic parameters were used as endpoint indicators to evaluate the pharmacokinetic characteristics of budesonide formoterol inhalation powder (II) (specification: 160μg/4.5μg) produced by Shanghai New Yellow River Pharmaceutical Co., Ltd. and budesonide formoterol inhalation powder (II) (Symbicort® Turbuhaler®, specification: 160μg/4.5μg) produced by AstraZeneca AB in humans, evaluate the bioequivalence of the test preparation and the reference preparation, and provide a reference basis for the registration application and clinical use of the drug.

Under the condition of fasting inhalation administration, the pharmacokinetic parameters were used as endpoint indicators to evaluate the pharmacokinetic characteristics of budesonide formoterol inhalation powder (II) (specification: 160μg/4.5μg) produced by Shanghai New Yellow River Pharmaceutical Co., Ltd. and budesonide formoterol inhalation powder (II) (Symbicort® Turbuhaler®, specification: 160μg/4.5μg) produced by AstraZeneca AB in humans, evaluate the bioequivalence of the test preparation and the reference preparation, and provide a reference basis for the registration application and clinical use of the drug.

Under the condition of fasting inhalation administration, the pharmacokinetic parameters were used as endpoint indicators to evaluate the pharmacokinetic characteristics of budesonide formoterol inhalation powder (II) (specification: 160μg/4.5μg) produced by Shanghai New Yellow River Pharmaceutical Co., Ltd. and budesonide formoterol inhalation powder (II) (Symbicort® Turbuhaler®, specification: 160μg/4.5μg) produced by AstraZeneca AB in humans. The rationality of the settings of the administration method and operation process, sampling volume, blood collection time, time interval, etc. and the feasibility of the detection method were investigated to provide a reference basis for formal trials.