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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Japan |
First Approval Date27 Oct 1961 |
/ CompletedNot Applicable [Translation] Bioequivalence test of cefixime granules
主要目的:健康受试者空腹、餐后口服头孢克肟颗粒(规格:50mg;生产厂家: 山西振东泰盛制药有限公司;受试制剂)与头孢克肟细粒(规格:50mg;生产厂家:Choseido Pharmaceutical Co.,Ltd.;商品名:Cefspan®;参比制剂),通过比较受试制剂与参比制剂的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性。次要目的:观察受试制剂头孢克肟颗粒和参比制剂头孢克肟细粒(Cefspan®)在健康受试者中的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of cefixime granules (specification: 50 mg; manufacturer: Shanxi Zhendong Taisheng Pharmaceutical Co., Ltd.; test preparation) and cefixime fine granules (specification: 50 mg; manufacturer: Choseido Pharmaceutical Co., Ltd.; trade name: Cefspan®; reference preparation) orally administered to healthy subjects on an empty stomach or after meals, and to compare the absorption rate and extent of the test preparation and the reference preparation. Secondary objective: To observe the safety of the test preparation cefixime granules and the reference preparation cefixime fine granules (Cefspan®) in healthy subjects.
/ CompletedNot Applicable 空腹和餐后状态下,两制剂、两周期、两序列、随机、交叉的头孢克肟胶囊人体生物等效性试验
[Translation] A two-preparation, two-cycle, two-sequence, randomized, crossover bioequivalence study of cefixime capsules in humans under fasting and fed conditions
以山西振东泰盛制药有限公司生产的头孢克肟胶囊为受试制剂,与Choseido Pharmaceutical Co.,Ltd.生产的头孢克肟胶囊(商品名:Cefspan®)为参比制剂进行生物等效性试验,考察空腹和餐后状态下两种头孢克肟胶囊在健康受试者体内的药代动力学参数及相对生物利用度,评价受试制剂与参比制剂是否是生物等效性制剂及安全性。
[Translation] A bioequivalence study was conducted using cefixime capsules produced by Shanxi Zhendong Taisheng Pharmaceutical Co., Ltd. as the test preparation and cefixime capsules (trade name: Cefspan®) produced by Choseido Pharmaceutical Co., Ltd. as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two cefixime capsules in healthy volunteers under fasting and postprandial conditions were investigated to evaluate whether the test preparation and the reference preparation are bioequivalent preparations and their safety.
/ Not yet recruitingPhase 2 [Translation] Phase IIa clinical trial of astragaloside sodium chloride injection
初步评价黄芪总皂苷氯化钠注射液治疗慢性稳定型心绞痛的安全性和有效性
[Translation] Preliminary evaluation of the safety and efficacy of astragaloside sodium chloride injection in the treatment of chronic stable angina pectoris
100 Clinical Results associated with Shanxi Taisheng Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Shanxi Taisheng Pharmaceutical Co., Ltd.
100 Deals associated with Shanxi Taisheng Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Shanxi Taisheng Pharmaceutical Co., Ltd.