/ CompletedNot Applicable 盐酸阿罗洛尔片在健康受试者中随机、开放、单剂量、两周期、两序列、交叉设计的空腹和餐后状态下生物等效性试验
[Translation] A randomized, open-label, single-dose, two-period, two-sequence, crossover-design bioequivalence study of arotinolol hydrochloride tablets in healthy subjects under fasting and fed conditions
主要研究目的
研究空腹和餐后状态下单次口服盐酸阿罗洛尔片受试制剂（规格：10 mg，湖南尚众合生物医药有限公司）与盐酸阿罗洛尔片参比制剂（Almarl®（阿尔马尔），规格：10 mg，Sumitomo Pharma Co.,Ltd.）在中国健康成年受试者体内的药代动力学，评价空腹和餐后单次口服两种制剂的生物等效性。
次要研究目的
评价中国健康受试者空腹和餐后单次口服受试制剂（T）盐酸阿罗洛尔片和参比制剂（R）盐酸阿罗洛尔片（商品名：Almarl®（阿尔马尔））后的安全性。
[Translation] Main study objectives
To study the pharmacokinetics of the test formulation of arotinolol hydrochloride tablets (specification: 10 mg, Hunan Shangzhonghe Biopharmaceutical Co., Ltd.) and the reference formulation of arotinolol hydrochloride tablets (Almarl®, specification: 10 mg, Sumitomo Pharma Co., Ltd.) in healthy Chinese adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two formulations after a single oral administration in the fasting and fed state.
Secondary study objectives
To evaluate the safety of the test formulation (T) arotinolol hydrochloride tablets and the reference formulation (R) arotinol hydrochloride tablets (trade name: Almarl®) after a single oral administration in healthy Chinese subjects after a fasting and fed state.
/ CompletedNot Applicable [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.
/ CompletedNot Applicable [Translation] Bioequivalence study of clopidogrel and aspirin 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氯吡格雷阿司匹林片受试制剂（规格：75mg/100mg，申办者：湖南尚众合生物医药有限公司）和参比制剂（商品名：多立维®，规格：75mg/100mg，持证商：Sanofi K.K.）后的药代动力学特点和生物等效性。
次要研究目的
研究氯吡格雷阿司匹林片受试制剂（规格：75mg/100mg）和参比制剂（商品名：多立维®，规格：75mg/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 a single oral dose of clopidogrel aspirin tablets (specification: 75mg/100mg, applicant: Hunan Shangzhonghe Biopharmaceutical Co., Ltd.) and a reference preparation (trade name: Duoliwei®, specification: 75mg/100mg, licensee: Sanofi K.K.) in healthy Chinese adult subjects under fasting and postprandial conditions.
Secondary study objectives
To study the safety of clopidogrel aspirin tablets (specification: 75mg/100mg) and a reference preparation (trade name: Duoliwei®, specification: 75mg/100mg) 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.
