/ CompletedNot Applicable [Translation] Study on the bioequivalence of cephalexin capsules 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,测定江苏贝
佳制药有限公司生产的头孢氨苄胶囊给药后头孢氨苄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Pragma Pharmaceuticals, LLC
生产的头孢氨苄胶囊[商品名:KEFLEX®]为参比,考察受试制剂的生物利用度,
评价制剂间的生物等效性,并观察头孢氨苄胶囊在中国健康受试者中的安全性。
[Translation] The study used Chinese healthy subjects as the test subjects and adopted a self-crossover design to determine the blood concentration of cephalexin in healthy subjects after administration of cephalexin capsules produced by Jiangsu Beijia Pharmaceutical Co., Ltd. over time, and estimated the corresponding pharmacokinetic parameters. The cephalexin capsules [trade name: KEFLEX®] produced by Pragma Pharmaceuticals, LLC were used as references to investigate the bioavailability of the test preparation, evaluate the bioequivalence between the preparations, and observe the safety of cephalexin capsules in Chinese healthy subjects.
/ RecruitingNot Applicable 头孢氨苄胶囊在健康受试者中开放、随机、单次给药、两周期、两序列、交叉空腹和餐后状态下的生物等效性试验
[Translation] An open, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study of cephalexin capsules in healthy volunteers under fasting and fed conditions
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,测定江苏贝佳制药有限公司生产的头孢氨苄胶囊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Pragma Pharmaceuticals, LLC生产的头孢氨苄胶囊[商品名:KEFLEX®]为参比,考察受试制剂的生物利用度,评价制剂间的生物等效性,并观察头孢氨苄胶囊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 blood drug concentration of Cephalexin Capsules produced by Jiangsu Beijia Pharmaceutical Co., Ltd. in healthy subjects, and the corresponding pharmacokinetic parameters were estimated. Cephalexin Capsules [trade name: KEFLEX®] produced by Pragma Pharmaceuticals, LLC was used as a reference to investigate the bioavailability of the test preparation, evaluate the bioequivalence between preparations, and observe the safety of Cephalexin Capsules in healthy Chinese subjects.
100 Clinical Results associated with Jiangsu Beijia Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Jiangsu Beijia Pharmaceutical Co., Ltd.
100 Deals associated with Jiangsu Beijia Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Jiangsu Beijia Pharmaceutical Co., Ltd.