Jewim Pharmaceutical (Shandong) Co., Ltd

Main research purpose: According to the relevant provisions of bioequivalence test, AstraZeneca Pty Ltd was selected as the reference preparation for budesonide suspension for inhalation (trade name: Pulmicort Respules®, specification: 2ml:1mg), and the test preparation budesonide suspension for inhalation (specification: 2ml:1mg) provided by Shandong Taihe Pharmaceutical Technology Co., Ltd. was used for fasting human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting conditions. Secondary research purpose: To observe the safety of oral inhalation of the test preparation budesonide suspension for inhalation (specification: 2ml:1mg) and the reference preparation budesonide suspension for inhalation (trade name: Pulmicort Respules®, specification: 2ml:1mg) in healthy subjects.

Main purpose: To study the bronchodilator effect of single oral inhalation of ipratropium bromide inhalation aerosol in different cycles in patients with chronic obstructive pulmonary disease (COPD), and to evaluate the PD-BE equivalence of the two preparations in COPD patients through a randomized, single-dose, crossover design, to provide support for the production registration application of the test preparation. Secondary purpose: To observe the safety of the test preparation and the reference preparation in COPD patients.

According to the relevant provisions of bioequivalence tests, Otsuka Pharmaceutical Co., Ltd. was selected as the reference preparation for the brepirazole tablets (trade name: REXULTI, specification: 2mg), and the test preparation brepirazole tablets (specification: 2mg) provided by Shandong Jingwei Pharmaceutical Co., Ltd. was subjected to a human bioequivalence test for fasting and postprandial administration. The absorption rate and degree of the drug in the test preparation were compared with those of the reference preparation to see if they were within an acceptable range, and the bioequivalence of the two preparations under fasting and postprandial administration conditions was evaluated. The safety of oral administration of the test preparation brepirazole tablets (specification: 2mg) and the reference preparation brepirazole tablets (trade name: REXULTI, specification: 2mg) was observed in healthy volunteers.