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 trial of oral administration of nicorandil tablets in Chinese healthy people under fasting and postprandial 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 purposes:
Investigate a single oral dose (fasting/after meal) of the test preparation nicorandil tablets (specification: 5 mg, sponsored by Benxi Jiangcheng Pharmaceutical Technology Co., Ltd.) and the reference preparation nicorandil tablets (Xigma®, specifications : 5 mg, licensed by Chugai Pharmaceutical Co., Ltd.), the relative bioavailability of the two preparations in healthy human subjects in China, the pharmacokinetic parameters of the two preparations, and the evaluation of the bioequivalence of the two preparations. Provide reference basis for clinical medication.
Secondary research purpose:
To evaluate the safety of the test preparation and reference preparation administered in single doses on an empty stomach or after a meal in healthy Chinese subjects.
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] Main research purpose: To investigate a single oral dose (fasting/after meals) of the test preparation pentoxifylline sustained-release tablets (specification: 400mg, sponsored by Benxi Jiangcheng Pharmaceutical Technology Co., Ltd.) and the reference preparation pentoxifylline sustained-release Tablets (Trental®, specification: 400mg, licensed by Sanofi), relative bioavailability in healthy human subjects in China, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations, in order to apply for the drug and Provide reference basis for clinical medication.
Secondary study objectives: To evaluate the safety of the test preparation and reference preparation administered in single doses on an empty stomach or after a meal 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] Single-center, randomized, open-label, two-sequence, two-cycle, crossover bioequivalence trial of dipyridamole tablets in Chinese healthy people under fasting and postprandial conditions
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] Main research purpose: To investigate a single oral dose (fasting/after meal) of the test preparation dipyridamole tablets (specification: 25 mg, sponsored by Benxi Jiangcheng Pharmaceutical Technology Co., Ltd.) and the reference preparation dipyridamole tablets (Persantin® , specification: 25mg, produced by Medical Parkland Co., Ltd.), relative bioavailability in healthy human subjects in China, analysis of the pharmacokinetic parameters of the two preparations, evaluation of the bioequivalence of the two preparations, and the application and clinical use of the drug Provide reference basis.
Secondary study objectives: To evaluate the safety of the test preparation and reference preparation administered in single doses on an empty stomach or after a meal in healthy Chinese subjects.
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