Chengdu Huide Pharmaceutical Technology Co Ltd

To evaluate the efficacy and safety of clevidipine butyrate injection emulsion in the treatment of patients with hypertensive emergencies and sub-emergencies

The main purpose of the study is to compare the pharmacokinetics of clevidipine butyrate emulsion for injection (specification: 50ml:25mg, test preparation T) developed by Shanghai No. 1 Biochemical Pharmaceutical Co., Ltd. and clevidipine butyrate emulsion for intravenous injection (Cleviprex®) produced by Chiesi USA, Inc (specification: 50ml:25mg, reference preparation R) in healthy subjects, and evaluate the bioequivalence of the two preparations by single-dose intravenous push administration in a single-center, randomized, open, two-period, double-crossover, postprandial state. Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Primary objective: To investigate the pharmacokinetic characteristics of clevidipine butyrate injection emulsion after single intravenous dose escalation in healthy subjects. Secondary objective: To evaluate the safety of clevidipine butyrate injection emulsion through laboratory tests, clinical symptoms, signs, adverse events/serious adverse events, etc.