Tianjin Jinyao Pharmaceutical Co., Ltd.

Primary study purpose: To investigate the pharmacokinetic parameters of the two preparations in humans by inhaling budesonide suspension for inhalation produced by Tianjin Jinyao Pharmaceutical Co., Ltd. (test preparation; specification: 2ml:1mg; 2ml/tube) and budesonide suspension for inhalation produced by AstraZeneca (reference preparation; specification: 2ml:1mg; 2ml/tube; English trade name: Pulmicort®, Chinese trade name: Pulmicort®) under activated carbon blocking conditions in healthy subjects on an empty stomach, and to evaluate the bioequivalence of the two preparations in healthy subjects under activated carbon blocking conditions. Secondary study purpose: To observe the safety of the test preparation (T) and the reference preparation (R) in healthy subjects.

Primary objective: To evaluate the bioequivalence of the test preparation of budesonide suspension for inhalation (specification: 2ml:1mg; 2ml/vial) produced by Tianjin Jinyao Pharmaceutical Co., Ltd. and the reference preparation of budesonide suspension for inhalation (specification: 2ml:1mg; 2ml/vial; English trade name: Pulmicort®, Chinese trade name: Pulmicort®) produced by Astrazeneca Pty Ltd in Chinese healthy adult subjects after single oral aerosol inhalation. Secondary objective: To evaluate the safety of the test preparation and reference preparation of budesonide suspension for inhalation in Chinese healthy adult subjects after single oral aerosol inhalation.

Celecoxib capsules produced by Tianjin Jinyao Pharmaceutical Co., Ltd. were used as the test preparation, and celecoxib capsules produced by Pfizer Inc. were used as the reference preparation to evaluate the bioequivalence of the two preparations and provide a theoretical basis for clinical safety and rational drug use. The safety of the test preparation and the reference preparation in healthy Chinese subjects was also observed.