[Translation] A single-center, randomized, open-label, crossover bioequivalence trial of fosphenytoin sodium injection in healthy participants.
主要目的:以药代动力学参数作为主要终点评价指标,比较在空腹状态下静脉注射受试制剂磷苯妥英钠注射液(规格:10 mL:500 mg(按 C15H11N2NaO2计),生产厂家:江苏金丝利药业股份有限公司)与参比制剂磷苯妥英钠注射液(规格:500 mg/10 mL(按 C15H11N2NaO2计),持证商:Parke Davis Div Warner Lambert Co,商品名:Cerebyx®),及参比制剂苯妥英钠注射液(规格:250 mg/5mL,持证商:Hikma Pharmaceuticals USA Inc.)后在健康试验参与者体内的药代动力学行为,评价受试制剂与参比制剂的生物等效性及疗效一致性。
[Translation] Primary Objective: To evaluate the bioequivalence and efficacy consistency of the test formulation and the reference formulation, fosphenytoin sodium injection (10 mL: 500 mg (calculated as C15H11N2NaO2), manufactured by Jiangsu Jinshili Pharmaceutical Co., Ltd.), after intravenous administration of the test formulation fosphenytoin sodium injection (500 mg/10 mL (calculated as C15H11N2NaO2), licensee: Parke Davis Div Warner Lambert Co., trade name: Cerebyx®), and the reference formulation phenytoin sodium injection (250 mg/5 mL, licensee: Hikma Pharmaceuticals USA Inc.), in healthy trial participants under fasting conditions, using pharmacokinetic parameters as the primary endpoint.