/ CompletedNot Applicable [Translation] Study on the bioequivalence of clopidogrel bisulfate tablets in healthy volunteers
主要研究目的:以赛诺菲(杭州)制药有限公司持证的硫酸氢氯吡格雷片(商品名:Plavix®,规格:75 mg)为参比制剂,以广东泉新泉益药业有限公司研发的硫酸氢氯吡格雷片(规格:75 mg)为受试制剂,通过单中心、随机、开放、单次给药、两序列、四周期、完全重复交叉临床研究来评价两种制剂的人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to use the clopidogrel bisulfate tablets (trade name: Plavix®, specification: 75 mg) certified by Sanofi (Hangzhou) Pharmaceutical Co., Ltd. as the reference preparation and the clopidogrel bisulfate tablets (specification: 75 mg) developed by Guangdong Quanxin Quanyi Pharmaceutical Co., Ltd. as the test preparation to evaluate the human bioequivalence of the two preparations through a single-center, randomized, open, single-dose, two-sequence, four-cycle, completely repeated crossover clinical study.
Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.
/ CompletedNot Applicable 他达拉非片随机、开放、单剂量、两制剂、交叉设计在中国健康受试者中的生物等效性正式试验
[Translation] A formal bioequivalence study of tadalafil tablets in Chinese healthy subjects using a randomized, open-label, single-dose, two-formulation, crossover design
主要目的:以广东泉新泉益药业有限公司提供的他达拉非片为受试制剂;并以Lilly del Caribe, Inc.生产的他达拉非片为参比制剂,进行人体相对生物利用度和生物等效性评价。
[Translation] Main objective: To evaluate the relative bioavailability and bioequivalence of tadalafil tablets provided by Guangdong Quanxin Quanyi Pharmaceutical Co., Ltd. as the test preparation and tadalafil tablets produced by Lilly del Caribe, Inc. as the reference preparation.
100 Clinical Results associated with Zhuhai Anbaojian Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Zhuhai Anbaojian Pharmaceutical Co., Ltd.
100 Deals associated with Zhuhai Anbaojian Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Zhuhai Anbaojian Pharmaceutical Co., Ltd.