[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Aspen Pharmacare Australia Pty Ltd为持证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,对江苏吴中医药集团有限公司苏州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)的安全性。
[Translation] Main research purpose: According to the relevant provisions of bioequivalence test, Aspen Pharmacare Australia Pty Ltd was selected as the reference preparation for the test preparation of leprocaine cream (specification: 1g: lidocaine 25mg, prilocaine 25mg) provided by Suzhou Pharmaceutical Factory of Jiangsu Wuzhong Pharmaceutical Group Co., Ltd. The human bioequivalence test of fasting administration was carried out to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting administration conditions.
Secondary research purpose: To observe the safety 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) applied externally to healthy subjects.