[Translation] A randomized open-label, two-cycle, crossover, two-sequence bioequivalence study of propofol medium/long-chain emulsion injection in healthy subjects under fasting state
以武汉滨湖双鹤药业有限责任公司生产,华润双鹤药业股份有限公司提供的丙泊酚中/长链脂肪乳注射液为受试制剂,按生物等效性试验的有关规定,与奥地利Fresenius Kabi Austria GmbH生产的丙泊酚中/长链脂肪乳注射液竟安®对比,进行两制剂在健康人体内的生物等效性研究和观察两制剂在健康人体内的药代动力学特征、药效学特征和安全性。
[Translation] Propofol medium/long-chain emulsion injection produced by Wuhan Binhu Double Crane Pharmaceutical Co., Ltd. and provided by China Resources Double Crane Pharmaceutical Co., Ltd. was used as the test preparation. According to the relevant provisions of the bioequivalence test, it was compared with Propofol medium/long-chain emulsion injection Jing'an® produced by Fresenius Kabi Austria GmbH, Austria, to conduct a bioequivalence study of the two preparations in healthy humans and observe the pharmacokinetic characteristics, pharmacodynamic characteristics and safety of the two preparations in healthy humans.