[Translation] A randomized, open-label, two-dose, two-period, double-crossover bioequivalence pilot study of clevidipine butyrate emulsion for injection in healthy volunteers under fasting conditions
1) 初步评估受试制剂北京世桥生物制药有限公司的丁酸氯维地平注射用乳剂 (50mL:25mg)和参比制剂 CHIESI USA INC 的丁酸氯维地平注射用乳剂 (50mL:25mg,商品名:Cleviprex®)的差异; 2) 指导正式试验设计; 3) 初步方法学验证; 4) 观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] 1) To preliminarily evaluate the differences between the test preparation, clevidipine butyrate injection emulsion (50mL:25mg) from Beijing Shiqiao Biopharmaceutical Co., Ltd. and the reference preparation, clevidipine butyrate injection emulsion (50mL:25mg, trade name: Cleviprex®) from CHIESI USA INC; 2) To guide the formal trial design; 3) To conduct preliminary methodological validation; 4) To observe the safety of the test preparation and the reference preparation in healthy subjects.