/ CompletedNot Applicable [Translation] Bioequivalence study of tranexamic acid tablets
主要研究目的
评价中国健康成年研究参与者空腹及餐后条件下单次单剂量口服氨甲环酸片受试制剂（规格：0.5g，申办者：安徽正善生物药业有限公司）和参比制剂（商品名：妥塞敏®（Transamin®），规格：0.5g，持证商：DAIICHI SANKYO CO.,LTD.）后的药代动力学特点和生物等效性。
次要研究目的
研究氨甲环酸片受试制剂（规格：0.5g）和参比制剂（商品名：妥塞敏®（Transamin®），规格：0.5g）在中国健康成年研究参与者中的安全性。
[Translation] Main study objectives
To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of tranexamic acid tablets (specification: 0.5g, applicant: Anhui Zhengshan Biopharmaceutical Co., Ltd.) and the reference formulation (trade name: Transamin®, specification: 0.5g, licensee: DAIICHI SANKYO CO., LTD.) after a single oral dose under fasting and postprandial conditions in healthy Chinese adult study participants.
Secondary study objectives
To study the safety of the test formulation of tranexamic acid tablets (specification: 0.5g) and the reference formulation (trade name: Transamin®, specification: 0.5g) in healthy Chinese adult study participants.
/ CompletedNot Applicable [Translation] Bioequivalence study of loxoprofen sodium 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洛索洛芬钠片受试制剂（规格：60mg，申办者：安徽正善生物药业有限公司）和参比制剂（商品名：乐松®，规格：60mg，持证商：第一三共制药（上海）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
研究洛索洛芬钠片受试制剂（规格：60mg）和参比制剂（商品名：乐松®，规格：60mg）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 loxoprofen sodium tablets (specification: 60 mg, applicant: Anhui Zhengshan Biopharmaceutical Co., Ltd.) and the reference formulation (trade name: Lesong®, specification: 60 mg, licensee: Daiichi Sankyo Pharmaceutical (Shanghai) Co., Ltd.) after a single oral dose in healthy Chinese adult subjects under fasting and postprandial conditions.
Secondary study objectives
To study the safety of the test formulation of loxoprofen sodium tablets (specification: 60 mg) and the reference formulation (trade name: Lesong®, specification: 60 mg) in healthy Chinese adult subjects.
/ CompletedNot Applicable [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.
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
