[Translation] A single-center, randomized, open-label, single-dose, fasting, two-formulation, two-sequence, two-period crossover bioequivalence study of leprocaine cream in healthy adult Chinese subjects
主要研究目的:
考察单次单剂量使用(空腹)受试制剂利丙双卡因乳膏15g【(规格:1g:利多卡因25mg,丙胺卡因25mg),海南凯健制药有限公司生产,长沙爱贝高药业有限公司提供】与参比制剂利丙双卡因乳膏15g(Emla,规格:1g:利多卡因25mg,丙胺卡因25mg,Recipharm Karlskoga AB生产,在中国健康人体的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性,为该药的申报及临床用药提供参考依据。
次要研究目的 评价空腹单次使用受试制剂和参比制剂在中国成年健康受试者中的安全性
[Translation] Main study objectives:
To investigate the relative bioavailability of the single-dose (fasting) test preparation leprocaine cream 15g [(Specification: 1g: lidocaine 25mg, prilocaine 25mg), produced by Hainan Kaijian Pharmaceutical Co., Ltd., provided by Changsha Aibeigao Pharmaceutical Co., Ltd.] and the reference preparation leprocaine cream 15g (Emla, Specification: 1g: lidocaine 25mg, prilocaine 25mg, produced by Recipharm Karlskoga AB) in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug.
Secondary study objectives To evaluate the safety of the test preparation and reference preparation in Chinese healthy adult subjects after single fasting