/ Not yet recruitingNot Applicable [Translation] Bioequivalence study of azithromycin dry suspension in human body
采用单中心、随机、开放、单剂量、三周期部分重复交叉、单次口服试验设计，比较空腹及餐后给药条件下，广东方盛融华药业有限公司提供的阿奇霉素干混悬剂（规格：0.1 g）与辉瑞制药有限公司持证的阿奇霉素干混悬剂（商品名：希舒美®，规格：0.1 g）在中国健康人群中吸收程度和吸收速度的差异，评价两制剂的生物等效性，并评价广东方盛融华药业有限公司提供的阿奇霉素干混悬剂的安全性。同时评价阿奇霉素干混悬剂在中国健康受试者中的适口性，为阿奇霉素干混悬剂用药口感提供依据。
[Translation] A single-center, randomized, open, single-dose, three-period partially repeated crossover, single oral trial design was used to compare the differences in absorption extent and absorption rate between azithromycin dry suspension (specification: 0.1 g) provided by Guangdong Fangsheng Ronghua Pharmaceutical Co., Ltd. and azithromycin dry suspension (trade name: Xishumei®, specification: 0.1 g) certified by Pfizer Pharmaceuticals Co., Ltd. in healthy Chinese people under fasting and postprandial administration conditions, evaluate the bioequivalence of the two preparations, and evaluate the safety of azithromycin dry suspension provided by Guangdong Fangsheng Ronghua Pharmaceutical Co., Ltd. At the same time, the palatability of azithromycin dry suspension in healthy Chinese subjects was evaluated to provide a basis for the taste of azithromycin dry suspension.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of loxoprofen sodium gel patch in healthy volunteers
主要目的：采用单中心、随机、开放、两制剂、双周期交叉、空腹试验设计，比较空腹给药条件下，广东方盛融华药业有限公司委托湖南方盛制药股份有限公司生产的洛索洛芬钠凝胶贴膏（每贴（14cm×10cm）含膏量10g，含洛索洛芬钠100mg（以C15H17NaO3计））与Lead Chemical Co.,Ltd持证的洛索洛芬钠凝胶贴膏（商品名：LOXONIN PAP®，规格：100mg/贴）在中国健康人群中吸收程度和吸收速度的差异，评价生物等效性。
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反应性。
[Translation] Primary objective: To compare the differences in the degree and rate of absorption of loxoprofen sodium gel patch (10g per patch (14cm×10cm) containing 100mg loxoprofen sodium (calculated as C15H17NaO3)) produced by Guangdong Fangsheng Ronghua Pharmaceutical Co., Ltd. and Hunan Fangsheng Pharmaceutical Co., Ltd. under fasting conditions, and to evaluate the bioequivalence.
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 in Chinese healthy subjects.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of flurbiprofen gel patch in healthy volunteers
主要目的：采用单中心、随机、开放、两制剂、双周期交叉、空腹试验设计，比较空腹给药
条件下，广东方盛融华药业有限公司提供的委托湖南方盛制药股份有限公司生产的氟比洛芬凝胶贴膏（每贴含氟比洛芬40 mg（面积 14 cm×10 cm，含膏量12 g））与 Mikasa Seiyaku Co.,Ltd 持证的氟比洛芬凝胶贴膏（每贴含氟比洛芬40 mg（面积13.6 cm×10 cm，含膏量12 g））在中国健康人群中吸收程度和吸收速度的差异，评价生物等效性。
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反应性。
[Translation] Primary objective: To compare the differences in the extent and rate of absorption of flurbiprofen gel patch (40 mg flurbiprofen per patch (14 cm×10 cm area, 12 g paste content)) provided by Guangdong Fangsheng Ronghua Pharmaceutical Co., Ltd. and commissioned by Hunan Fangsheng Pharmaceutical Co., Ltd. under fasting administration conditions and evaluate bioequivalence in healthy Chinese populations. 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 reactivity of the test preparation and the reference preparation in healthy Chinese subjects.
100 Clinical Results associated with Guangdong Fangsheng Ronghua Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Guangdong Fangsheng Ronghua Pharmaceutical Co., Ltd.
100 Deals associated with Guangdong Fangsheng Ronghua Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Guangdong Fangsheng Ronghua Pharmaceutical Co., Ltd.
