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Inactive Indication- |
Drug Highest PhasePreclinical |
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/ Not yet recruitingNot Applicable 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[规格:每贴含氟比洛芬40mg(面积13.6cm×10.0cm,含膏量12g);商品名:泽普思®(Zepolas®)]为参比制剂,以汕头经济特区明治医药有限公司研制的氟比洛芬凝胶贴膏[规格: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 [specification: each patch contains 40 mg of flurbiprofen (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 [specification: each patch (area 13.6 cm × 10.0 cm) contains 12 g of paste, containing 40 mg of flurbiprofen] developed by Shantou Special Economic Zone Meiji Pharmaceutical 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 of Chinese healthy subjects;
3) To evaluate the skin reactivity of the test preparation and the reference preparation to Chinese healthy subjects.
/ Active, not recruitingNot Applicable 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
以持证商为MIKASA SEIYAKU CO.,LTD的氟比洛芬凝胶贴膏[规格:每贴含氟比洛芬40mg(面积13.6cm×10.0cm,含膏量12g);商品名:泽普思®(Zepolas®)]为参比制剂,以汕头经济特区明治医药有限公司研制的氟比洛芬凝胶贴膏[规格: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。
[Translation] Flurbiprofen gel patch [specification: each patch contains 40 mg of flurbiprofen (area 13.6 cm×10.0 cm, paste content 12 g); trade name: Zepolas®] produced by MIKASA SEIYAKU CO., LTD. was used as the reference preparation, and flurbiprofen gel patch [specification: each patch (area 13.6 cm×10.0 cm) contains 12 g of paste and 40 mg of flurbiprofen] developed by Shantou SEZ Meiji Pharmaceutical Co., Ltd. was used as the test preparation to evaluate the bioequivalence of the two preparations under topical use conditions in Chinese healthy subjects.
100 Clinical Results associated with Shantou SEZ Meiji Pharmaceuticals Co., Ltd.
0 Patents (Medical) associated with Shantou SEZ Meiji Pharmaceuticals Co., Ltd.
100 Deals associated with Shantou SEZ Meiji Pharmaceuticals Co., Ltd.
100 Translational Medicine associated with Shantou SEZ Meiji Pharmaceuticals Co., Ltd.