甲磺酸多沙唑嗪缓释片在健康受试者中的随机、开放、单剂量、双周期、自身交叉空腹及餐后生物等效性研究
[Translation] Randomized, open-label, single-dose, double-cycle, self-crossover fasting and postprandial bioequivalence study of doxazosin mesylate extended-release tablets in healthy subjects
主要研究目的:以Pfizer Pharmaceuticals LLC生产的甲磺酸多沙唑嗪缓释片(规格:4 mg,以多沙唑嗪计,商品名:可多华®/Cardura®XL)为参比制剂(R),以南京易亨制药有限公司研制的甲磺酸多沙唑嗪缓释片(规格:4 mg,以多沙唑嗪计)为受试制剂(T),研究受试制剂和参比制剂在空腹和高脂餐后条件下单剂量给药时的药代动力学参数,进行人体生物等效性评价。
次要研究目的:比较甲磺酸多沙唑嗪缓释片受试制剂和参比制剂(商品名:可多华®/Cardura®XL)在健康受试者中的安全性。
[Translation] Main research purpose: Doxazosin mesylate sustained-release tablets produced by Pfizer Pharmaceuticals LLC (specification: 4 mg, calculated as doxazosin, trade name: Cardura®/Cardura®XL) are used as the reference preparation ( R), taking the doxazosin mesylate sustained-release tablets (specification: 4 mg, calculated as doxazosin) developed by Nanjing Yiheng Pharmaceutical Co., Ltd. as the test preparation (T), study the test preparation and reference The pharmacokinetic parameters of the preparation when administered as a single dose under fasting and high-fat meal conditions were evaluated for human bioequivalence.
Secondary study purpose: To compare the safety of the test preparation and reference preparation (trade name: Cardura®/Cardura®XL) of doxazosin mesylate sustained-release tablets in healthy subjects.
伏立康唑干混悬剂在健康受试者中的随机、开放、单次给药、两周期、双交叉空腹生物等效性试验
[Translation] Randomized, open-label, single-dose, two-cycle, double-crossover fasting bioequivalence trial of voriconazole dry suspension in healthy subjects
主要目的:以南京易亨制药有限公司生产的伏立康唑干混悬剂(规格:45 g:3 g)为受试制剂,按生物等效性试验的有关规定,与Pfizer Europe MA EEIG 持证、Fareva Amboise生产的伏立康唑干混悬剂为参比制剂(商品名:威凡,规格:45 g:3 g),对比在健康人体内的相对生物利用度,研究两制剂的人体生物等效性。
次要目的:观察伏立康唑干混悬剂受试制剂和参比制剂(威凡)在健康受试者中的安全性。
[Translation] Main purpose: Using voriconazole dry suspension (specification: 45 g: 3 g) produced by Nanjing Yiheng Pharmaceutical Co., Ltd. as the test preparation, according to the relevant regulations of bioequivalence testing, with Pfizer Europe MA EEIG Certificate, Fareva The voriconazole dry suspension produced by Amboise is a reference preparation (trade name: Weifan, specification: 45 g: 3 g). The relative bioavailability in healthy humans is compared to study the human bioequivalence of the two preparations.
Secondary purpose: To observe the safety of voriconazole dry suspension test preparation and reference preparation (Vivan) in healthy subjects.
米拉贝隆缓释片在健康受试者中的随机、开放、四周期、两序列、完全重复交叉空腹及餐后生物等效性试验
[Translation] A randomized, open-label, four-period, two-sequence, complete repeat crossover fasting and postprandial bioequivalence study of mirabegron sustained-release tablets in healthy subjects
主要目的:以南京易亨制药有限公司生产的米拉贝隆缓释片(50 mg)为受试制剂,按生物等效性试验的有关规定,与Astellas Pharma Europe B.V.持证,Avara Pharmaceutical Technologies, Inc.生产,安斯泰来制药(中国)有限公司分装的米拉贝隆缓释片(参比制剂,贝坦利®,规格:50 mg)对比在健康人体内的相对生物利用度,研究两制剂的空腹和餐后条件下人体生物等效性。
次要目的:观察米拉贝隆缓释片受试制剂和参比制剂(贝坦利®)在健康受试者中的安全性。
[Translation] Main purpose: Taking Mirabegron Sustained-release Tablets (50 mg) produced by Nanjing Yiheng Pharmaceutical Co., Ltd. as the test preparation, according to the relevant regulations of bioequivalence testing, it is licensed with Astellas Pharma Europe B.V., Avara Pharmaceutical Technologies, Inc., manufactured by Astellas Pharmaceuticals (China) Co., Ltd., and compared the relative bioavailability of Mirabegron sustained-release tablets (reference preparation, Betanly®, specification: 50 mg) in healthy humans, To study the human bioequivalence of the two preparations under fasting and postprandial conditions.
Secondary purpose: To observe the safety of Mirabegron sustained-release tablet test preparation and reference preparation (Betanly®) in healthy subjects.
100 Clinical Results associated with Nanjing Yiheng Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Nanjing Yiheng Pharmaceutical Co., Ltd.
100 Deals associated with Nanjing Yiheng Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Nanjing Yiheng Pharmaceutical Co., Ltd.