[Translation] A single-dose, randomized, open-label, two-period, double-crossover bioequivalence study of leprocaine cream (leprocaine cream, containing 25 mg lidocaine and 25 mg prilocaine per gram) and EMLA (leprocaine cream, containing 25 mg lidocaine and 25 mg prilocaine per gram) in healthy male and female subjects
主要研究目的:在健康男性和女性受试者中评价利丙双卡因乳膏和EMLA的吸收速度和吸收程度,评价两制剂间是否具有生物等效性。
次要研究目的:评估受试制剂利丙双卡因乳膏和参比制剂EMLA在健康受试者中的安全性。
[Translation] Primary study objective: To evaluate the absorption rate and extent of leprocaine cream and EMLA in healthy male and female subjects, and to evaluate whether the two preparations are bioequivalent.
Secondary study objective: To evaluate the safety of the test preparation leprocaine cream and the reference preparation EMLA in healthy subjects.