/ CompletedNot Applicable [Translation] Bioequivalence study of Nicorandil tablets in healthy volunteers
以中国健康受试者为试验对象,采用自身交叉对照的试验设计,测定北京沃邦医药科技有限公司持证,扬州市三药制药有限公司生产的尼可地尔片给药后的血浆中尼可地尔在健康受试者体内的血药浓度经时过程,估算相应的药代动力学参数,并以Chugai Pharmaceutical Co.,Ltd.持证Nipro Pharma Corporation Kagamiishi Plant生产的尼可地尔片【商品名:Sigmart(喜格迈)】为参比,评价制剂间的生物等效性,并观察尼可地尔片在中国健康受试者中的安全性。
[Translation] Healthy Chinese subjects were used as test subjects. A self-crossover design was used to determine the time course of plasma concentration of nicorandil in healthy subjects after administration of Nicorandil tablets produced by Yangzhou Sanyao Pharmaceutical Co., Ltd. and licensed by Beijing Wobang Pharmaceutical Technology Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Nicorandil tablets [trade name: Sigmart] produced by Nipro Pharma Corporation Kagamiishi Plant, licensed by Chugai Pharmaceutical Co., Ltd. were used as reference to evaluate the bioequivalence between the preparations and to observe the safety of Nicorandil tablets in healthy Chinese subjects.
100 Clinical Results associated with Beijing Voban Pharmaceutical Technology Co., Ltd.
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