[Translation] The clevidipine butyrate injection emulsion developed by Shanghai Shanghai Pharma First Biochemical Pharmaceutical Co., Ltd. and the intravenous injection clevidipine butyrate (trade name: Cleviprex®) produced by Chiesi USA, Inc in healthy subjects in China A single-center, randomized, open-label, two-cycle, double-crossover, single-dose intravenous bolus bioequivalence trial of
主要研究目的:比较上海上药第一生化药业有限公司研制的丁酸氯维地平注射用乳剂(规格:50ml:25mg,受试制剂T)与Chiesi USA, Inc生产的静脉注射用乳剂丁酸氯维地平(clevidipine butyrate,商品名Cleviprex®)(规格:50ml:25mg,参比制剂R)在健康受试者体内的药代动力学,通过单中心、随机、开放、两周期、双交叉、餐后状态下单剂量静脉推注给药,评价两种制剂的人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Main research purpose: To compare the clevidipine butyrate injection emulsion (specification: 50ml:25mg, test preparation T) developed by Shanghai Shanghai Pharma First Biochemical Pharmaceutical Co., Ltd. with the intravenous injection butyrate emulsion produced by Chiesi USA, Inc. Pharmacokinetics of clevidipine (clevidipine butyrate, trade name Cleviprex®) (specification: 50ml:25mg, reference preparation R) in healthy subjects, through single-center, randomized, open, two-cycle, double-crossover, The human bioequivalence of the two formulations was evaluated by single-dose intravenous bolus administration in the postprandial state.
Secondary research objectives: To observe the safety of the test preparation and reference preparation in healthy Chinese subjects.