[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of prilocaine cream (1 g: lidocaine 25 mg, prilocaine 25 mg) in Chinese healthy subjects under fasting conditions
主要研究目的:按有关生物等效性试验的规定,选择Recipharm Karlskoga AB为生产商的利丙双卡因乳膏(商品名:Emla,规格:1g:利多卡因25mg,丙胺卡因25mg)为参比制剂,对竟天生物科技制药工厂 生产,澳美制药厂提供的受试制剂利丙双卡因乳膏(规格:1g:利多卡因25mg,丙胺卡因25mg)进行空腹给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在空腹给药条件下的生物等效性。
次要研究目的:观察中国健康受试者外用受试制剂利丙双卡因乳膏(规格:1g:利多卡因25mg,丙胺卡因25mg)和参比制剂利丙双卡因乳膏(商品名:Emla,规格:1g:利多卡因25mg,丙胺卡因25mg)后的安全性。
[Translation] Main research purpose: According to the relevant provisions of bioequivalence test, the leprocaine cream (trade name: Emla, specification: 1g: lidocaine 25mg, prilocaine 25mg) produced by Recipharm Karlskoga AB was selected as the reference preparation, and the test preparation leprocaine cream (specification: 1g: lidocaine 25mg, prilocaine 25mg) produced by Jingtian Biotechnology Pharmaceutical Factory and provided by Aome Pharmaceutical Factory was subjected to a human bioequivalence test on an empty stomach. The absorption rate and degree of the drug in the test preparation were compared with those of the reference preparation to see if they were within an acceptable range, and to evaluate the bioequivalence of the two preparations under the condition of fasting administration.
Secondary research purpose: To observe the safety of Chinese healthy subjects after external application of the test preparation leprocaine cream (specification: 1g: lidocaine 25mg, prilocaine 25mg) and the reference preparation leprocaine cream (trade name: Emla, specification: 1g: lidocaine 25mg, prilocaine 25mg).