洛索洛芬钠凝胶贴膏在中国健康受试者外用条件下单次给药的人体生物等效性临床试验
[Translation] Human bioequivalence clinical trial of loxoprofen sodium gel patch under the condition of external application in Chinese healthy volunteers
主要目的: 以持证商为LEAD CHEMICAL CO.,LTD.的洛索洛芬钠凝胶膏(100mg/贴,商品名为LOXONIN® PAP)为参比制剂,以湖南金圃医药科技有限公司研制的洛索洛芬钠凝胶贴膏[每贴(14cm×10cm)含膏体10g,含洛索洛芬钠(以C15H17NaO3计)100mg]为受试制剂,通过单中心、随机、开放、单次给药、两制剂、两周期、四序列、交叉设计的临床试验来评价两种制剂在中国健康受试者中外用条件下的生物等效性。
次要目的:
1)评价受试制剂与参比制剂在中国健康受试者中的安全性;
2)评价受试制剂与参比制剂在中国健康受试者用药过程中的粘附性;
3)评价受试制剂与参比制剂对中国健康受试者的皮肤反应性。
[Translation] Main purpose: To develop the loxoprofen sodium gel paste (100mg/paste, trade name LOXONIN® PAP) with licensee LEAD CHEMICAL CO., LTD. as the reference preparation, and Hunan Jinpu Pharmaceutical Technology Co., Ltd. Loxoprofen sodium gel patch [each patch (14cm×10cm) contains 10g of paste, containing 100mg of loxoprofen sodium (calculated as C15H17NaO3)] as the test preparation, through a single center, random, open, single A single-dose, two-drug, two-period, four-sequence, crossover design clinical trial was conducted to evaluate the bioequivalence of two preparations under topical conditions in Chinese healthy subjects.
Secondary purpose:
1) Evaluate the safety of the test preparation and the reference preparation in Chinese healthy subjects;
2) Evaluate the adhesion of the test preparation and the reference preparation in the course of administration to Chinese healthy subjects;
3) To evaluate the skin reactivity of the test preparation and the reference preparation to Chinese healthy subjects.
氟比洛芬凝胶贴膏在中国健康受试者外用条件下单次给药的人体生物
等效性临床试验
[Translation] Human biological effects of a single dose of flurbiprofen gel patch under topical conditions in Chinese healthy subjects
equivalence clinical trials
以持证商为Mikasa Seiyaku Co.,Ltd的氟比洛芬凝胶贴膏(40mg/贴,商品名为泽普思®)为参比制剂,以湖南金圃医药科技有限公司研制的氟比洛芬凝胶贴膏(40mg/贴)为受试制剂,通过单中心、随机、开放、单次给药、两制剂、两周期、四序列、交叉设计的临床试验来评价两种制剂在中国健康受试者中外用条件下的生物等效性。
次要目的: 1)评价受试制剂与参比制剂在中国健康受试者中的安全性;
2)评价受试制剂与参比制剂在中国健康受试者用药过程中的粘附性;
3)评价受试制剂与参比制剂对中国健康受试者的皮肤反应性。
[Translation] The flurbiprofen gel patch (40mg/paste, trade name Zepusi®) with the licensee Mikasa Seiyaku Co., Ltd. as the reference preparation, and the flurbiprofen gel patch developed by Hunan Jinpu Pharmaceutical Technology Co., Ltd Profen Gel Plaster (40mg/paste) is the test preparation, and the clinical trials of two preparations, two cycles, four sequences, and crossover design are used to evaluate the clinical trials of two preparations in China. Bioequivalence under topical conditions in healthy subjects.
Secondary purposes: 1) To evaluate the safety of the test preparation and the reference preparation in Chinese healthy subjects;
2) Evaluate the adhesion of the test preparation and the reference preparation in the course of administration to Chinese healthy subjects;
3) To evaluate the skin reactivity of the test preparation and the reference preparation to Chinese healthy subjects.
100 Clinical Results associated with Hunan Jinpu Pharmaceutical Technology Co., Ltd.
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100 Translational Medicine associated with Hunan Jinpu Pharmaceutical Technology Co., Ltd.