[Translation] Bioequivalence study of rosuvastatin ezetimibe tablets (Ⅰ)
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受试制剂瑞舒伐他汀依折麦布片（Ⅰ）（规格：10mg/10mg，申办者：湖南尚众合生物医药有限公司）和参比制剂依折麦布瑞舒伐他汀钙片（商品名：Zenon®Neo，规格：依折麦布10mg/瑞舒伐他汀10mg，持证商：Sanofi-Aventis，S.R.O.）后的药代动力学特点和生物等效性。
次要研究目的 研究受试制剂瑞舒伐他汀依折麦布片（Ⅰ）（规格：10mg/10mg）和参比制剂依折麦布瑞舒伐他汀钙片（商品名：Zenon®Neo，规格：依折麦布10mg/瑞舒伐他汀10mg）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 preparation rosuvastatin ezetimibe tablets (I) (specification: 10mg/10mg, applicant: Hunan Shangzhonghe Biopharmaceutical Co., Ltd.) and the reference preparation ezetimibe rosuvastatin calcium tablets (trade name: Zenon®Neo, specification: ezetimibe 10mg/rosuvastatin 10mg, licensee: Sanofi-Aventis, S.R.O.) 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 preparation rosuvastatin ezetimibe tablets (I) (specification: 10mg/10mg) and the reference preparation ezetimibe rosuvastatin calcium tablets (trade name: Zenon®Neo, specification: ezetimibe 10mg/rosuvastatin 10mg) in healthy Chinese adult subjects.
[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：湖南尚众合生物医药有限公司）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: Hunan Shangzhonghe 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 mesalazine enteric-coated 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美沙拉秦肠溶片受试制剂（规格：0.5g，申办者：湖南尚众合生物医药有限公司）和参比制剂（商品名：Salofalk®，规格：0.5g，持证商：Dr.Falk Pharma GmbH）后的药代动力学特点和生物等效性。
次要研究目的
研究美沙拉秦肠溶片受试制剂（规格：0.5g）和参比制剂（商品名：Salofalk®，规格：0.5g）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 mesalazine enteric-coated tablets (specification: 0.5g, applicant: Hunan Shangzhonghe Biopharmaceutical Co., Ltd.) and the reference formulation (trade name: Salofalk®, specification: 0.5g, licensee: Dr.Falk Pharma GmbH) 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 mesalazine enteric-coated tablets (specification: 0.5g) and the reference formulation (trade name: Salofalk®, specification: 0.5g) in healthy Chinese adult subjects.
100 Clinical Results associated with Hunan Shangzhonghe Biopharmaceutical Co., Ltd.
0 Patents (Medical) associated with Hunan Shangzhonghe Biopharmaceutical Co., Ltd.
100 Deals associated with Hunan Shangzhonghe Biopharmaceutical Co., Ltd.
100 Translational Medicine associated with Hunan Shangzhonghe Biopharmaceutical Co., Ltd.
