/ Not yet recruitingNot Applicable [Translation] Study on the bioequivalence of diclofenac diethylamine emulsion in healthy volunteers
主要目的：比较空腹给药条件下，湖南派格兰药业有限公司提供的双氯芬酸二乙胺乳胶剂（规格：2.32%（50 g：1.16 g，以C18H22Cl2N2O2计））与Haleon UK Trading Limited持证的双氯芬酸二乙胺乳胶剂（商品名：Voltarol®；规格：2.32%（50 g：1.16 g，以C18H22Cl2N2O2计））在中国健康人群吸收程度和吸收速度的差异。
次要目的：
评价空腹给药条件下，湖南派格兰药业有限公司提供的双氯芬酸二乙胺乳胶剂（规格：2.32%（50 g：1.16 g，以C18H22Cl2N2O2计））与Haleon UK Trading Limited持证的双氯芬酸二乙胺乳胶剂（商品名：Voltarol®；规格：2.32%（50 g：1.16 g，以C18H22Cl2N2O2计））在中国健康人群体内的安全性。
[Translation] Main purpose: To compare the differences in absorption degree and absorption rate of diclofenac diethylamine emulsion (specification: 2.32% (50 g: 1.16 g, calculated as C18H22Cl2N2O2)) provided by Hunan Paiglan Pharmaceutical Co., Ltd. and diclofenac diethylamine emulsion (trade name: Voltarol®; specification: 2.32% (50 g: 1.16 g, calculated as C18H22Cl2N2O2)) certified by Haleon UK Trading Limited in healthy Chinese population under fasting administration conditions.
Secondary objective: To evaluate the safety of diclofenac diethylamine emulsion (specification: 2.32% (50 g: 1.16 g, calculated as C18H22Cl2N2O2)) provided by Hunan Paiglan Pharmaceutical Co., Ltd. and diclofenac diethylamine emulsion (trade name: Voltarol®; specification: 2.32% (50 g: 1.16 g, calculated as C18H22Cl2N2O2)) certified by Haleon UK Trading Limited in healthy Chinese population under fasting conditions.
/ Active, not recruitingNot Applicable [Translation] Study on the bioequivalence of loxoprofen sodium gel patch in healthy volunteers
主要目的：
比较受试制剂湖南派格兰药业有限公司提供的洛索洛芬钠凝胶贴膏（规格：每贴（14 cm×10 cm）含膏体10 g，含洛索洛芬钠100 mg（按C15H17NaO3计））与参比制剂Lead Chemical Co., Ltd持证的洛索洛芬钠凝胶贴膏（商品名：LOXONIN PAP®，规格：100 mg/贴）在中国健康人群中吸收程度和吸收速度的差异。
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黏附性；3）评价受试制剂与参比制剂对中国健康受试者的皮肤刺激性。
[Translation] Primary objective:
To compare the differences in absorption degree and absorption rate between the test preparation loxoprofen sodium gel patch provided by Hunan Paiglan Pharmaceutical Co., Ltd. (specification: each patch (14 cm×10 cm) contains 10 g of paste and 100 mg of loxoprofen sodium (calculated as C15H17NaO3)) and the reference preparation loxoprofen sodium gel patch certified by Lead Chemical Co., Ltd (trade name: LOXONIN PAP®, specification: 100 mg/patch) in healthy Chinese subjects.
Secondary objectives:
1) To evaluate the safety of the test preparation and the reference preparation in healthy Chinese subjects; 2) To evaluate the adhesion of the test preparation and the reference preparation during medication in healthy Chinese subjects; 3) To evaluate the skin irritation of the test preparation and the reference preparation to healthy Chinese subjects.
100 Clinical Results associated with Hunan Paiglan Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Hunan Paiglan Pharmaceutical Co., Ltd.
100 Deals associated with Hunan Paiglan Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Hunan Paiglan Pharmaceutical Co., Ltd.
