铝镁匹林片（Ⅱ）在中国健康人群中空腹和餐后状态下单次给药的人体生物等效性临床试验
[Translation] A human bioequivalence clinical trial of a single dose of Al-Mg-Pirine tablets (II) in Chinese healthy subjects under fasting and fed conditions
主要目的： 以持证商为 Lion Corporation 的铝镁匹林片（Ⅱ）（商品名：BUFFERIN Combination Tab. A81，规格：每片含阿司匹林 81mg，重质碳酸镁 22mg，甘羟铝 11mg）为参比制剂，以湖南金圃医药科技有限公司研发的铝镁匹林片（Ⅱ）（规格：每片含阿司匹林 81mg，重质碳酸镁22mg，甘羟铝 11mg）为受试制剂，评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。
次要目的： 评价受试制剂与参比制剂在中国健康受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the two preparations in the fasting and fed state in healthy Chinese subjects, using the aluminum magnesium aspirin tablets (II) (trade name: BUFFERIN Combination Tab. A81, specification: each tablet contains 81 mg aspirin, 22 mg heavy magnesium carbonate, 11 mg aluminum glycolate) from Lion Corporation as the reference preparation and the aluminum magnesium aspirin tablets (II) (specification: each tablet contains 81 mg aspirin, 22 mg heavy magnesium carbonate, 11 mg aluminum glycolate) developed by Hunan Jinpu Pharmaceutical Technology Co., Ltd. as the test preparation. Secondary objective: To evaluate the safety of the test preparation and the reference preparation in healthy Chinese 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] A human bioequivalence clinical trial of flurbiprofen gel patch in Chinese healthy volunteers after single administration under topical conditions
主要目的：
以持证商为MIKASA SEIYAKU CO.,LTD的氟比洛芬凝胶贴膏（每贴含氟比洛芬40mg（面积13.6cm×10.0cm，含膏量12g），商品名为泽普思® （Zepolas®））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（每贴（面积13.6cm×10.0cm）含膏体12g，含氟比洛芬40mg）为受试制剂，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:
Using the flurbiprofen gel patch (containing 40 mg of flurbiprofen per patch (area 13.6 cm × 10.0 cm, containing 12 g of paste), trade name Zepolas®) of the licensed manufacturer MIKASA SEIYAKU CO., LTD as the reference preparation, and the flurbiprofen gel patch (containing 12 g of paste per patch (area 13.6 cm × 10.0 cm), containing 40 mg of flurbiprofen) developed by Hunan Jinpu Pharmaceutical Technology Co., Ltd. as the test preparation, the bioequivalence of the two preparations under topical conditions in Chinese healthy subjects was evaluated.
Secondary objectives:
1) To evaluate the safety of the test preparation and the reference preparation in Chinese healthy subjects;
2) To evaluate the adhesion of the test preparation and the reference preparation during the medication process in Chinese healthy subjects;
3) To evaluate the skin reactivity of the test preparation and the reference preparation in Chinese healthy subjects.
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] A human bioequivalence clinical trial of loxoprofen sodium gel patch in Chinese healthy volunteers after single administration under topical conditions
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: Using loxoprofen sodium gel paste (100 mg/patch, trade name LOXONIN® PAP) from LEAD CHEMICAL CO., LTD. as the reference preparation and loxoprofen sodium gel paste developed by Hunan Jinpu Pharmaceutical Technology Co., Ltd. [each patch (14 cm×10 cm) contains 10 g of paste and 100 mg of loxoprofen sodium (calculated as C15H17NaO3)] as the test preparation, a single-center, randomized, open, single-dose, two-preparation, two-period, four-sequence, crossover clinical trial was conducted to evaluate the bioequivalence of the two preparations under topical conditions in Chinese healthy subjects.
Secondary objectives:
1) To evaluate the safety of the test preparation and the reference preparation in Chinese healthy subjects;
2) To evaluate the adhesion of the test preparation and the reference preparation during medication in Chinese healthy subjects;
3) To evaluate the skin reactivity of the test preparation and the reference preparation in Chinese healthy subjects.
100 Clinical Results associated with Hunan Jinpu Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Hunan Jinpu Pharmaceutical Technology Co., Ltd.
100 Deals associated with Hunan Jinpu Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Hunan Jinpu Pharmaceutical Technology Co., Ltd.
