/ CompletedNot Applicable 双丙戊酸钠缓释片在中国健康志愿者中空腹及餐后状态下的人体生物等效性试验
[Translation] Human bioequivalence study of divalproex sodium extended-release tablets in Chinese healthy volunteers under fasting and fed conditions
观察双丙戊酸钠缓释片在中国健康受试者中单次口服给药后的丙戊酸体内动力学过程,估算相应的药代动力学参数,并以Abbvie Inc持证的Depakote® Er为参比制剂,进行等效性评价。
[Translation] To observe the in vivo kinetics of valproate after a single oral administration of divalproex sodium extended-release tablets in healthy Chinese subjects, estimate the corresponding pharmacokinetic parameters, and conduct an equivalence evaluation using Depakote® Er licensed by Abbvie Inc as the reference preparation.
/ CompletedNot Applicable 随机、开放、单剂量、两制剂、交叉对照设计,评价中国健康受试者在空腹及餐后状态下单次口服尼可地尔片后的生物等效性正式试验
[Translation] A randomized, open-label, single-dose, two-formulation, crossover controlled study to evaluate the bioequivalence of a single oral dose of nicorandil tablets in Chinese healthy subjects in the fasting and fed state
主要目的:以山东信谊制药有限公司提供的尼可地尔片为受试制剂,按生物等效性试验的有关规定,与Chugai Pharmaceutical Co., Ltd.持证的尼可地尔片对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
[Translation] Main objective: To compare the absorption rate and extent of Nicorandil tablets provided by Shandong Xinyi Pharmaceutical Co., Ltd. with those of Nicorandil tablets certified by Chugai Pharmaceutical Co., Ltd. in healthy human bodies according to the relevant provisions of bioequivalence studies, and to investigate the bioequivalence of the two preparations in humans.
/ CompletedNot Applicable 尼可地尔片随机、开放、交叉设计在中国健康受试者中的药代动力学研究
[Translation] A randomized, open-label, crossover study of the pharmacokinetics of nicorandil tablets in healthy Chinese subjects
以山东信谊制药有限公司的尼可地尔片为受试制剂;并以Chugai Pharmaceutical Co., Ltd.的尼可地尔片为参比制剂,进行人体药代动力学研究,确认试验方案的科学性及合理性。
[Translation] Nicorandil tablets produced by Shandong Xinyi Pharmaceutical Co., Ltd. were used as the test preparation, and Nicorandil tablets produced by Chugai Pharmaceutical Co., Ltd. were used as the reference preparation to conduct human pharmacokinetic studies to confirm the scientificity and rationality of the experimental plan.
100 Clinical Results associated with Shandong Sine Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Shandong Sine Pharmaceutical Co., Ltd.
100 Deals associated with Shandong Sine Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Shandong Sine Pharmaceutical Co., Ltd.