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Drug Highest PhaseApproved |
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First Approval Date20 Mar 2014 |
正元胶囊治疗化疗相关性癌因性疲乏有效性和安全性的随机、双盲、安慰剂平行对照、多中心Ⅱ期临床试验
[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial on the efficacy and safety of Zhengyuan Capsule in the treatment of chemotherapy-related cancer fatigue
主要目的:
评价正元胶囊治疗化疗相关性癌因性疲乏有效性和安全性;
次要目的:
评价正元胶囊对患者生存质量的影响;
探索免疫功能指标、神经内分泌功能指标与癌因性疲乏及正元胶囊的关系。
[Translation] Main purpose:
To evaluate the effectiveness and safety of Zhengyuan capsule in the treatment of chemotherapy-related cancer-related fatigue;
Secondary purpose:
To evaluate the effect of Zhengyuan capsule on the quality of life of patients;
To explore the relationship between immune function indicators, neuroendocrine function indicators, cancer-related fatigue and Zhengyuan capsule.
氨氯地平贝那普利胶囊在健康受试者中空腹和餐后状态下随机、开放、两周期、双交叉生物等效性临床试验
[Translation] A randomized, open-label, two-period, double-crossover bioequivalence clinical trial of amlodipine-benazepril capsules in healthy subjects under fasting and fed conditions
主要目的:研究空腹和餐后状态下单次口服氨氯地平贝那普利胶囊受试制剂(规格:氨氯地平5mg; 盐酸贝那普利10mg,扬子江药业集团广州海瑞药业有限公司)与参比制剂(商品名:Lotrel,规格:氨氯地平5mg; 盐酸贝那普利10mg,Novartis Pharmaceuticals Corporation)在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性;
次要目的:观察受试制剂和参比制剂(商品名:Lotrel)在健康受试者中的安全性。
[Translation] Primary objective: To study the pharmacokinetic behavior of the test formulation of amlodipine benazepril capsules (specifications: amlodipine 5mg; benazepril hydrochloride 10mg, Yangtze River Pharmaceutical Group Guangzhou Hairui Pharmaceutical Co., Ltd.) and the reference formulation (trade name: Lotrel, specifications: amlodipine 5mg; benazepril hydrochloride 10mg, Novartis Pharmaceuticals Corporation) in healthy subjects after a single oral administration in fasting and postprandial states, and to evaluate the bioequivalence of the two formulations; Secondary objective: To observe the safety of the test formulation and the reference formulation (trade name: Lotrel) in healthy subjects.
硫酸氢氯吡格雷片单剂量、随机、开放、交叉空腹状态下健康人体生物等效性试验
[Translation] A single-dose, randomized, open-label, crossover bioequivalence study of clopidogrel bisulfate tablets in healthy volunteers under fasting conditions
比较健康成年人群在空腹状态下,单次口服扬子江药业集团广州海瑞药业有限公司生产的硫酸氢氯吡格雷片(75mg)与Sanofi Winthrop Industrie, France生产、赛诺菲(杭州)制药有限公司分装的硫酸氢氯吡格雷片(商品名:波立维,75mg)后两种制剂人体药代动力学特点,评估两种制剂间的生物等效性及安全性。
[Translation] To compare the pharmacokinetic characteristics of a single oral dose of clopidogrel bisulfate tablets (75 mg) produced by Guangzhou Hairui Pharmaceutical Co., Ltd. of Yangtze River Pharmaceutical Group and clopidogrel bisulfate tablets (trade name: Plavix, 75 mg) produced by Sanofi Winthrop Industrie, France and packaged by Sanofi (Hangzhou) Pharmaceutical Co., Ltd. in healthy adults under fasting state, and to evaluate the bioequivalence and safety of the two preparations.
100 Clinical Results associated with Yangtze River Pharmaceutical Group Guangzhou Hairui Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Yangtze River Pharmaceutical Group Guangzhou Hairui Pharmaceutical Co., Ltd.
100 Deals associated with Yangtze River Pharmaceutical Group Guangzhou Hairui Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Yangtze River Pharmaceutical Group Guangzhou Hairui Pharmaceutical Co., Ltd.