/ CompletedNot Applicable 利丙双卡因乳膏随机、开放、两制剂、两周期、单次给药、双交叉设计在中国健康受试者中的药代动力学研究
[Translation] A randomized, open-label, two-formulation, two-period, single-dose, double-crossover pharmacokinetic study of leprocaine cream in healthy Chinese subjects
主要研究目的
考察健康受试者在空腹状态下，单次涂抹由济南百润医药科技有限公司提供的利丙双卡因乳膏（受试制剂T，规格：每克含利多卡因25mg和丙胺卡因25mg）和由Aspen Pharma Trading Limited持证的利丙双卡因乳膏（参比制剂R，商品名：EMLA®，规格：每克含利多卡因25mg和丙胺卡因25mg）的药代动力学特征，评价两种制剂的生物等效性。
次要研究目的
观察健康受试者单次涂抹受试制剂利丙双卡因乳膏（规格：每克含利多卡因25mg和丙胺卡因25mg）或参比制剂利丙双卡因乳膏（商品名：EMLA®，规格：每克含利多卡因25mg和丙胺卡因25mg）的安全性。
[Translation] Main study objectives
To investigate the pharmacokinetic characteristics of the leprocaine cream (test preparation T, specification: 25 mg lidocaine and 25 mg prilocaine per gram) provided by Jinan Bairun Pharmaceutical Technology Co., Ltd. and the leprocaine cream (reference preparation R, trade name: EMLA®, specification: 25 mg lidocaine and 25 mg prilocaine per gram) certified by Aspen Pharma Trading Limited in the fasting state, and to evaluate the bioequivalence of the two preparations.
Secondary study objectives
To observe the safety of the test preparation leprocaine cream (specification: 25 mg lidocaine and 25 mg prilocaine per gram) or the reference preparation leprocaine cream (trade name: EMLA®, specification: 25 mg lidocaine and 25 mg prilocaine per gram) in healthy subjects after a single application.
/ Not yet recruitingNot Applicable 利丙双卡因乳膏随机、开放、两制剂、两周期、单次给药、双交叉设计在中国健康受试者中的药代动力学研究
[Translation] A randomized, open-label, two-formulation, two-period, single-dose, double-crossover pharmacokinetic study of leprocaine cream in healthy Chinese subjects
主要研究目的
考察健康受试者在空腹状态下，单次涂抹由济南百润医药科技有限公司提供的利丙双卡因乳膏（受试制剂T，规格：每克含利多卡因25mg和丙胺卡因25mg）和由Aspen Pharma Trading Limited持证的利丙双卡因乳膏（参比制剂R，商品名：EMLA®，规格：每克含利多卡因25mg和丙胺卡因25mg）的药代动力学特征，评价两种制剂的生物等效性。
次要研究目的
观察健康受试者单次涂抹受试制剂利丙双卡因乳膏（规格：每克含利多卡因25mg和丙胺卡因25mg）或参比制剂利丙双卡因乳膏（商品名：EMLA®，规格：每克含利多卡因25mg和丙胺卡因25mg）的安全性。
[Translation] Main study objectives
To investigate the pharmacokinetic characteristics of the leprocaine cream (test preparation T, specification: 25 mg lidocaine and 25 mg prilocaine per gram) provided by Jinan Bairun Pharmaceutical Technology Co., Ltd. and the leprocaine cream (reference preparation R, trade name: EMLA®, specification: 25 mg lidocaine and 25 mg prilocaine per gram) certified by Aspen Pharma Trading Limited in the fasting state, and to evaluate the bioequivalence of the two preparations.
Secondary study objectives
To observe the safety of the test preparation leprocaine cream (specification: 25 mg lidocaine and 25 mg prilocaine per gram) or the reference preparation leprocaine cream (trade name: EMLA®, specification: 25 mg lidocaine and 25 mg prilocaine per gram) in healthy subjects after a single application.
100 Clinical Results associated with Jinan Bairun Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Jinan Bairun Pharmaceutical Technology Co., Ltd.
100 Deals associated with Jinan Bairun Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Jinan Bairun Pharmaceutical Technology Co., Ltd.
