[Translation] Clinical study plan for a randomized, open-label, two-dose, two-period, double-crossover, fasting bioequivalence trial of etomidate emulsion injection in healthy subjects
主要研究目的: 以四川国瑞药业有限责任公司研制生产的依托咪酯乳状注射液(规格:10mL:20mg) 为受试制剂, B.Braun Melsungen AG 生产的依托咪酯乳状注射液(商品名:Etomidat-Lipuro®, 规格: 10mL:20mg) 为参比制剂,研究两制剂在中国健康受试者体内的药代动力学参数,评价两周期分别单次输注受试制剂或参比制剂是否具有生物等效性;次要研究目的:观察依托咪酯乳状注射液在健康人群中的的药效动力学参数,评价两制剂的药效动力学等效性;同时评价依托咪酯乳状注射液的人体耐受性和安全性
[Translation] Main research purpose: Using etomidate emulsion injection (specification: 10mL:20mg) developed and produced by Sichuan Guorui Pharmaceutical Co., Ltd. as the test preparation, and etomidate emulsion injection (trade name: Etomidat-Lipuro®, specification: 10mL:20mg) produced by B.Braun Melsungen AG as the reference preparation, the pharmacokinetic parameters of the two preparations in healthy Chinese subjects were studied, and whether single infusion of the test preparation or the reference preparation in two cycles was bioequivalent; Secondary research purpose: Observe the pharmacodynamic parameters of etomidate emulsion injection in healthy people, evaluate the pharmacodynamic equivalence of the two preparations; and evaluate the human tolerability and safety of etomidate emulsion injection