吸入用布地奈德混悬液在中国健康受试者中空腹给药条件下随机、开放、单剂量、两制剂、交叉生物等效性试验临床试验
[Translation] A randomized, open-label, single-dose, two-drug, crossover bioequivalence trial of budesonide suspension for inhalation in Chinese healthy subjects under fasting conditions
主要研究目的:按有关生物等效性试验的规定,选择AstraZeneca Pty Ltd为持证商的吸入用布地奈德混悬液(商品名:普米克令舒®,规格:2ml:1mg)为参比制剂,对山东泰合医药科技有限公司提供的受试制剂吸入用布地奈德混悬液(规格:2ml:1mg)进行空腹给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评估两种制剂在空腹给药条件下的生物等效性。
次要研究目的:观察健康受试者经口吸入受试制剂吸入用布地奈德混悬液(规格:2ml:1mg)和参比制剂吸入用布地奈德混悬液(商品名:普米克令舒®,规格:2ml:1mg)的安全性。
[Translation] 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.
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