[Translation] Bioequivalence study of Eperisone Hydrochloride Tablets
主要研究目的
评价中国健康成年受试者空腹及餐后条件下单次单剂量口服盐酸乙哌立松片受试制剂（规格：50mg，申办者：安徽正善生物药业有限公司）和参比制剂（商品名：妙纳®，规格：50mg，持证商：卫材（中国）药业有限公司）后的药代动力学特点和生物等效性。
次要研究目的
研究盐酸乙哌立松片受试制剂（规格：50mg）和参比制剂（商品名：妙纳®，规格：50mg）在中国健康成年受试者中的安全性。
[Translation] Main study objectives
To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of eperisone hydrochloride tablets (specification: 50 mg, applicant: Anhui Zhengshan Biopharmaceutical Co., Ltd.) and the reference formulation (trade name: Miaona®, specification: 50 mg, licensee: Eisai (China) Pharmaceutical Co., Ltd.) after a single oral dose under fasting and postprandial conditions in healthy Chinese adult subjects.
Secondary study objectives
To study the safety of the test formulation of eperisone hydrochloride tablets (specification: 50 mg) and the reference formulation (trade name: Miaona®, specification: 50 mg) in healthy Chinese adult subjects.
[Translation] Bioequivalence study of Iguratimod tablets
主要研究目的
评价中国健康成年受试者空腹及餐后条件下单次单剂量口服艾拉莫德片受试制剂（规格：25mg，申办者：安徽正善生物药业有限公司）和参比制剂（商品名：艾得辛®，规格：25mg，持证商：海南先声药业有限公司）后的药代动力学特点和生物等效性。
次要研究目的
研究艾拉莫德片受试制剂（规格：25mg）和参比制剂（商品名：艾得辛®，规格：25mg）在中国健康成年受试者中的安全性。
[Translation] Main study objectives
To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of Iguratimod tablets (specification: 25 mg, applicant: Anhui Zhengshan Biopharmaceutical Co., Ltd.) and the reference formulation (trade name: Edexin®, specification: 25 mg, licensee: Hainan Xiansheng Pharmaceutical Co., Ltd.) after a single oral dose under fasting and postprandial conditions in healthy Chinese adult subjects.
Secondary study objectives
To study the safety of the test formulation of Iguratimod tablets (specification: 25 mg) and the reference formulation (trade name: Edexin®, specification: 25 mg) in healthy Chinese adult subjects.
[Translation] Bioequivalence study of fluvoxamine maleate tablets
主要研究目的
评价中国健康成年受试者空腹及餐后条件下单次单剂量口服马来酸氟伏沙明片受试制剂（规格：100mg，申办者：安徽正善生物药业有限公司）和参比制剂（商品名：Luvox®（兰释®），规格：100mg，持证商：Abbott Laboratories (Singapore) Private Limited）后的药代动力学特点和生物等效性。
次要研究目的
研究马来酸氟伏沙明片受试制剂（规格：100mg）和参比制剂（商品名：Luvox®（兰释®），规格：100mg）在中国健康成年受试者中的安全性。
[Translation] Main study objectives
To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of fluvoxamine maleate tablets (specification: 100 mg, applicant: Anhui Zhengshan Biopharmaceutical Co., Ltd.) and the reference formulation (trade name: Luvox®, specification: 100 mg, licensee: Abbott Laboratories (Singapore) Private Limited) in healthy Chinese adult subjects after a single oral dose under fasting and postprandial conditions.
Secondary study objectives
To study the safety of the test formulation of fluvoxamine maleate tablets (specification: 100 mg) and the reference formulation (trade name: Luvox®, specification: 100 mg) in healthy Chinese adult subjects.
100 Clinical Results associated with An Hui Zheng Shan Sheng Wu Yao Ye You Xian Gong Si
0 Patents (Medical) associated with An Hui Zheng Shan Sheng Wu Yao Ye You Xian Gong Si
100 Deals associated with An Hui Zheng Shan Sheng Wu Yao Ye You Xian Gong Si
100 Translational Medicine associated with An Hui Zheng Shan Sheng Wu Yao Ye You Xian Gong Si
