/ Active, not recruitingNot Applicable 盐酸丁螺环酮片（15mg）在中国健康受试者中空腹及餐后给药条件下随机、开放、单剂量、两制剂、交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-formulation, crossover bioequivalence study of buspirone hydrochloride tablets (15 mg) in healthy Chinese subjects under fasting and fed conditions
以浙江高跖医药科技股份有限公司的盐酸丁螺环酮片为受试制剂；并以Teva Pharmaceuticals USA Inc.持证的盐酸丁螺环酮片为参比制剂，进行人体相对生物利用度和生物等效性评价
[Translation] Buspirone hydrochloride tablets from Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd. were used as the test preparation, and buspirone hydrochloride tablets certified by Teva Pharmaceuticals USA Inc. were used as the reference preparation to evaluate the relative bioavailability and bioequivalence in humans.
/ Active, not recruitingNot Applicable 艾普拉唑肠溶片在健康受试者中随机、开放、单剂量、两制剂、交叉对照的生物等效性研究
[Translation] A randomized, open-label, single-dose, two-formulation, crossover bioequivalence study of ilaprazole enteric-coated tablets in healthy volunteers
以浙江高跖医药科技股份有限公司的艾普拉唑肠溶片为受试制剂；并以丽珠集团丽珠制药厂持证的艾普拉唑肠溶片为参比制剂，进行生物等效性正式试验。
[Translation] A formal bioequivalence test was conducted using ilaprazole enteric-coated tablets produced by Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd. as the test preparation, and ilaprazole enteric-coated tablets certified by Livzon Pharmaceutical Factory of Livzon Group as the reference preparation.
/ CompletedNot Applicable 美阿沙坦钾片在健康受试者中餐后状态下的开放、随机、交叉生物等效性试验
[Translation] An open, randomized, crossover bioequivalence study of Asartan Potassium Tablets in healthy volunteers in the fed state
主要试验目的
研究餐后状态下单次口服受试制剂美阿沙坦钾片（规格：80mg，浙江华润三九众益制药有限公司生产）与参比制剂美阿沙坦钾片（商品名：易达比®；规格：80mg；Takeda Ireland Ltd.生产）在健康受试者体内的药代动力学，评价餐后状态口服两种制剂的生物等效性。
次要试验目的
评估受试制剂美阿沙坦钾片（规格：80mg）与参比制剂易达比®（规格：80mg）在健康受试者中的安全性。
[Translation] Main study objectives
To study the pharmacokinetics of the test preparation, Asartan Potassium Tablets (Specification: 80 mg, produced by Zhejiang China Resources Sanjiu Zhongyi Pharmaceutical Co., Ltd.) and the reference preparation, Asartan Potassium Tablets (trade name: Edabi®; Specification: 80 mg; produced by Takeda Ireland Ltd.) in healthy subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state.
Secondary study objectives
To evaluate the safety of the test preparation, Asartan Potassium Tablets (Specification: 80 mg) and the reference preparation, Edabi® (Specification: 80 mg) in healthy subjects.
100 Clinical Results associated with Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd
0 Patents (Medical) associated with Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd
100 Deals associated with Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd
100 Translational Medicine associated with Zhejiang Gaozhi Pharmaceutical Technology Co., Ltd
