[Translation] A randomized, open-label, two-agent, single-dose, two-cycle crossover bioequivalence trial of BUD under activated carbon blockade in healthy Chinese subjects
要研究目的:考察健康受试者在活性炭阻断条件下,空腹吸入天津金耀药业有限公司生产的吸入用布地奈德混悬液(受试制剂;规格:2ml:1mg;2ml/支)与AstraZeneca公司生产的吸入用布地奈德混悬液(参比制剂;规格:2ml:1mg;2ml/支;英文商品名:Pulmicort®,中文商品名:普米克令舒),比较两制剂在人体内的药代动力学参数,评价活性炭阻断条件下两种制剂在健康受试者体内的生物等效性。
次要研究目的:观察受试制剂(T)和参比制剂(R)在健康受试者中的安全性。
[Translation] Research purpose: To investigate healthy subjects who inhaled budesonide suspension for inhalation produced by Tianjin Jinyao Pharmaceutical Co., Ltd. on an empty stomach under the condition of activated carbon blockade (test preparation; specification: 2ml:1mg; 2ml/piece) Compared with the budesonide suspension for inhalation produced by AstraZeneca (reference preparation; specification: 2ml:1mg; 2ml/piece; English trade name: Pulmicort®, Chinese trade name: Pulmicort®), compare the two preparations in human. In vivo pharmacokinetic parameters to evaluate the bioequivalence of the two formulations in healthy subjects under activated charcoal blocking conditions.
Secondary research objectives: To observe the safety of the test product (T) and the reference product (R) in healthy subjects.