/ Not yet recruitingNot Applicable [Translation] Study on the bioequivalence of leprocaine cream in healthy volunteers
主要目的:采用单中心、随机、开放、双周期交叉、空腹试验设计比较健康受试者单次使用渼颜空间(河北)生物科技有限公司提供的利丙双卡因乳膏(规格:30 g(1 g:利多卡因25 mg,丙胺卡因25 mg))与Aspen Pharma Trading Limited持证的原研进口利丙双卡因乳膏(商品名:EMLA®,规格:30 g(1 g:利多卡因25 mg,丙胺卡因25 mg))在中国健康人群中吸收程度和吸收速度的差异,评价生物等效性。
次要目的:评价利丙双卡因乳膏(规格:1 g:利多卡因25 mg,丙胺卡因25 mg)受试制剂和参比制剂在健康受试者体内的安全性。
[Translation] Primary objective: To compare the differences in the extent and rate of absorption of the single-use leprocaine cream (specification: 30 g (1 g: lidocaine 25 mg, prilocaine 25 mg)) provided by Meiyan Space (Hebei) Biotechnology Co., Ltd. and the original imported leprocaine cream (trade name: EMLA®, specification: 30 g (1 g: lidocaine 25 mg, prilocaine 25 mg)) certified by Aspen Pharma Trading Limited in healthy Chinese subjects using a single-center, randomized, open, two-period crossover, fasting trial design, and evaluate the bioequivalence.
Secondary objective: To evaluate the safety of the test and reference preparations of leprocaine cream (specification: 1 g: lidocaine 25 mg, prilocaine 25 mg) in healthy subjects.
100 Clinical Results associated with Beijing Meiyan Space Biomedical Co., Ltd
0 Patents (Medical) associated with Beijing Meiyan Space Biomedical Co., Ltd
100 Deals associated with Beijing Meiyan Space Biomedical Co., Ltd
100 Translational Medicine associated with Beijing Meiyan Space Biomedical Co., Ltd