/ Not yet recruitingNot Applicable [Translation] Bioequivalence study of Nicorandil tablets in healthy volunteers
本试验旨在研究单次空腹和餐后口服黑龙江亿达鸿药业有限公司研制、生产的尼可地尔片（5 mg）的药代动力学特征；以Chugai Pharmaceutical Co.,Ltd持证、Nipro Pharma Corporation Kagamiishi Plant生产的尼可地尔片（喜格迈®，5 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。
[Translation] This study aimed to study the pharmacokinetic characteristics of nicorandil tablets (5 mg) developed and produced by Heilongjiang Yidahong Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal; using nicorandil tablets (Xigemai®, 5 mg) produced by Chugai Pharmaceutical Co., Ltd and Nipro Pharma Corporation Kagamiishi Plant as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.
/ RecruitingNot Applicable [Translation] Study on the bioequivalence of betahistine hydrochloride tablets in human body
本试验旨在研究单次空腹和餐后口服黑龙江亿达鸿药业有限公司研制、生产的盐酸倍他司汀片（8 mg）的药代动力学特征；以Mylan Laboratories SAS生产的盐酸倍他司汀片（Serc®，8 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。
[Translation] The purpose of this study was to study the pharmacokinetic characteristics of betahistine hydrochloride tablets (8 mg) developed and produced by Heilongjiang Yidahong Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration; using betahistine hydrochloride tablets (Serc®, 8 mg) produced by Mylan Laboratories SAS as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.
/ CompletedNot Applicable 双嘧达莫片在健康人体空腹/餐后状态下的生物等效性试验
[Translation] Bioequivalence study of dipyridamole tablets in healthy volunteers under fasting/fed conditions
主要目的：以黑龙江亿达鸿药业有限公司生产的双嘧达莫片（规格：25mg）为受试制剂，按生物等效性试验的有关规定，以Nippon Boehringer Ingelheim Co., Ltd.持证的双嘧达莫片（商品名：Persantin，规格：25mg）为参比制剂，进行空腹/餐后状态下人体生物等效性试验，评价受试制剂和参比制剂在健康受试者体内的生物等效性。
次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: Dipyridamole tablets (specification: 25 mg) produced by Heilongjiang Yidahong Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of the bioequivalence test, dipyridamole tablets (trade name: Persantin, specification: 25 mg) certified by Nippon Boehringer Ingelheim Co., Ltd. were used as the reference preparation. Human bioequivalence tests were conducted in the fasting/postprandial state to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.
100 Clinical Results associated with Heilongjiang Yidahong Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Heilongjiang Yidahong Pharmaceutical Co., Ltd.
100 Deals associated with Heilongjiang Yidahong Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Heilongjiang Yidahong Pharmaceutical Co., Ltd.
