[Translation] A single-center, randomized, open-label, two-dose, four-period, four-crossover, fasting pharmacokinetic study of budesonide suspension for inhalation in healthy volunteers under non-charcoal-blocked/charcoal-blocked conditions
以海门普适医药有限公司生产的吸入用布地奈德混悬液为受试制剂,以AstraZeneca Pty Ltd生产的吸入用布地奈德混悬液(商品名:普米克令舒®/PULMICORT RESPULES®)为参比制剂,研究空腹非炭阻断/炭阻断状态下,单次使用两种制剂时,健康志愿者体内的药动学特征,验证分析方法、评估变异程度、优化采样时间,估算相应的药代动力学参数;观察健康志愿者单次使用受试制剂和参比制剂的安全性。
[Translation] Using budesonide suspension for inhalation produced by Haimen Pushi Pharmaceutical Co., Ltd as the test preparation, and budesonide suspension for inhalation produced by AstraZeneca Pty Ltd (trade name: Pulmicort Respules®/PULMICORT RESPULES®) as the reference preparation, the pharmacokinetic characteristics of the two preparations in healthy volunteers when used once under fasting non-carbon-blocked/carbon-blocked conditions were studied, the analytical methods were verified, the degree of variation was evaluated, the sampling time was optimized, and the corresponding pharmacokinetic parameters were estimated; the safety of single use of the test preparation and the reference preparation in healthy volunteers was observed.