[Translation] A single-center, randomized, open-label, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of leprocaine cream in healthy Chinese adult subjects under fasting conditions
主要目的:以南京瑞捷医药科技有限公司提供的利丙双卡因乳膏(规格:1g:利多卡因25mg,丙胺卡因25mg,杭州领业医药科技有限公司生产)为受试制剂,以Aspen Pharmacare Australia Pty Ltd 持证的利丙双卡因乳膏(商品名:Emla,规格:1g:利多卡因25mg,丙胺卡因25mg)为参比制剂,通过单中心、随机、开放、单次给药、两序列、两周期、双交叉临床研究来评价两种制剂在空腹状态下的人体生物等效性。次要目的:评价利丙双卡因乳膏受试制剂T和参比制剂R在健康受试者中的安全性 。
[Translation] Primary objective: To evaluate the bioequivalence of the two preparations in the fasting state in humans by using the leprocaine cream (specification: 1g: lidocaine 25mg, prilocaine 25mg, produced by Hangzhou Lingye Pharmaceutical Technology Co., Ltd.) provided by Nanjing Ruijie Pharmaceutical Technology Co., Ltd. as the test preparation and the leprocaine cream (trade name: Emla, specification: 1g: lidocaine 25mg, prilocaine 25mg) certified by Aspen Pharmacare Australia Pty Ltd as the reference preparation through a single-center, randomized, open, single-dose, two-sequence, two-period, double-crossover clinical study. Secondary objective: To evaluate the safety of the test preparation T and reference preparation R of leprocaine cream in healthy subjects.