/ CompletedNot 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成都天之翼尚品医药科技有限公司持证浙江经纬药业有限公司生产的利丙双卡因乳膏(规格:30g(1g:利多卡因25mg,丙胺卡因25mg))与Aspen Pharma Trading Limited持证的欧盟上市未进口的利丙双卡因乳膏(商品名:EMLA®,规格:30g(1g:利多卡因25mg,丙胺卡因25mg))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:30g(1g:利多卡因25mg,丙胺卡因25mg))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 degree and rate of absorption of the single-use lipocaine cream (specification: 30g (1g: lidocaine 25mg, prilocaine 25mg)) produced by Zhejiang Jingwei Pharmaceutical Co., Ltd. and licensed by Chengdu Tianzhiyi Shangpin Pharmaceutical Technology Co., Ltd. and the lipocaine cream (trade name: EMLA®, specification: 30g (1g: lidocaine 25mg, prilocaine 25mg)) not imported into the EU market and licensed by Aspen Pharma Trading Limited in healthy Chinese subjects by 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 lipocaine cream (specification: 30g (1g: lidocaine 25mg, prilocaine 25mg)) in healthy subjects.
100 Clinical Results associated with Tibet Manshanhong Pharmaceutical Co., Ltd.
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100 Deals associated with Tibet Manshanhong Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Tibet Manshanhong Pharmaceutical Co., Ltd.