己酮可可碱缓释片在中国健康人群中空腹和餐后状态下口服给药的生物等效性试验
[Translation] Bioequivalence study of pentoxifylline sustained-release tablets in Chinese healthy subjects under fasting and fed conditions
主要研究目的：考察单次单剂量口服（空腹/餐后）受试制剂己酮可可碱缓释片（规格：400mg，本溪匠成医药科技有限公司申办）与参比制剂己酮可可碱缓释片（Trental®，规格：400mg，Sanofi 持证），在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为该药的申报及临床用药提供参考依据。
次要研究目的：评价空腹、餐后单次口服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 investigate the relative bioavailability of the single-dose oral (fasting/postprandial) test preparation pentoxifylline sustained-release tablets (specification: 400mg, applied for by Benxi Jiangcheng Pharmaceutical Technology Co., Ltd.) and the reference preparation pentoxifylline sustained-release tablets (Trental®, specification: 400mg, Sanofi certified) in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug.
Secondary purpose of the study: To evaluate the safety of the test preparation and reference preparation in Chinese healthy subjects after single oral administration on an empty stomach or after a meal.
尼可地尔片在中国健康人群中空腹和餐后状态下口服给药的生物等效性试验
[Translation] Bioequivalence study of oral administration of nicorandil tablets in Chinese healthy subjects under fasting and fed conditions
主要研究目的：
考察单次单剂量口服（空腹/餐后）受试制剂尼可地尔片（规格：5mg，本溪匠成医药科技有限公司申办）与参比制剂尼可地尔片（喜格迈®，规格：5mg，Chugai Pharmaceutical Co.，Ltd.持证），在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为该药的申报及临床用药提供参考依据。
次要研究目的：
评价空腹、餐后单次口服受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Main research objectives:
To investigate the relative bioavailability of the single-dose oral (fasting/postprandial) test preparation Nicorandil Tablets (Specification: 5mg, applied for by Benxi Jiangcheng Pharmaceutical Technology Co., Ltd.) and the reference preparation Nicorandil Tablets (Sigma®, Specification: 5mg, licensed by Chugai Pharmaceutical Co., Ltd.) in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug.
Secondary research objectives:
To evaluate the safety of the single oral fasting and postprandial test preparations and reference preparations in healthy Chinese subjects.
双嘧达莫片在中国健康人群中空腹和餐后状态下单中心、随机、开放、两序列、两周期、交叉生物等效性试验
[Translation] A single-center, randomized, open-label, two-sequence, two-period, crossover bioequivalence study of dipyridamole tablets in the fasting and fed state in healthy Chinese people
主要研究目的：考察单次单剂量口服（空腹/餐后）受试制剂双嘧达莫片（规格：25mg，本溪匠成医药科技有限公司申办）与参比制剂双嘧达莫片（Persantin®，规格：25mg，株式会社Medical Parkland 生产），在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为该药的申报及临床用药提供参考依据。
次要研究目的：评价空腹、餐后单次口服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 investigate the relative bioavailability of a single oral dose (fasting/postprandial) of the test preparation dipyridamole tablets (specification: 25 mg, applied for by Benxi Jiangcheng Pharmaceutical Technology Co., Ltd.) and the reference preparation dipyridamole tablets (Persantin®, specification: 25 mg, produced by Medical Parkland Co., Ltd.) in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug.
Secondary purpose of the study: To evaluate the safety of the test preparation and the reference preparation in Chinese healthy subjects after a single oral administration on an empty stomach or after a meal.
100 Clinical Results associated with Benxi Jiangcheng Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Benxi Jiangcheng Pharmaceutical Technology Co., Ltd.
100 Deals associated with Benxi Jiangcheng Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Benxi Jiangcheng Pharmaceutical Technology Co., Ltd.
