/ CompletedNot Applicable 盐酸昂丹司琼片单中心、单剂量、随机、开放、交叉生物等效性试验
[Translation] A single-center, single-dose, randomized, open-label, crossover bioequivalence trial of ondansetron hydrochloride tablets.
主要目的:以四川依科制药有限公司的盐酸昂丹司琼片(规格:8mg(按C18H19N3O计))为受试制剂,以BEXAL FARMACéUTICA, S.A.为持证商的盐酸昂丹司琼片(规格:8mg(按C18H19N3O计);商品名:ZOFRAN ®)为参比制剂,按生物等效性试验的有关规定,考察两制剂在健康人体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康试验参与者中的安全性。
[Translation] Primary objective: To investigate the bioequivalence of ondansetron hydrochloride tablets (8 mg (C18H19N3O)) manufactured by Sichuan Yike Pharmaceutical Co., Ltd. as the test formulation and ondansetron hydrochloride tablets (8 mg (C18H19N3O); trade name: ZOFRAN®) manufactured by BEXAL FARMACéUTICA, S.A. as the reference formulation in healthy human subjects, in accordance with the relevant regulations for bioequivalence studies.
Secondary objective: To observe the safety of the test and reference formulations in healthy trial participants.
/ CompletedNot Applicable 富马酸伏诺拉生片在健康人体空腹/餐后状态下的随机、开放、双周期、双交叉设计生物等效性试验
[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of vonoprazan fumarate tablets in healthy subjects under fasting/postprandial conditions.
主要目的:本研究以四川依科制药有限公司持证的富马酸伏诺拉生片(规格:20mg(按C17H16FN3O2S计))为受试制剂,Takeda Pharmaceutical Company Limited持证的富马酸伏诺拉生片(商品名:沃克,规格:20mg(按C17H16FN3O2S计))为参比制剂,进行空腹/餐后状态下人体生物等效性试验,评价受试制剂和参比制剂在健康参与者体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康参与者中的安全性。
[Translation] Primary Objective: This study used vonoprazan fumarate tablets (20 mg (C17H16FN3O2S)) certified by Sichuan Yike Pharmaceutical Co., Ltd. as the test formulation and vonoprazan fumarate tablets (trade name: Walker, 20 mg (C17H16FN3O2S)) certified by Takeda Pharmaceutical Company Limited as the reference formulation. A human bioequivalence study was conducted under fasting and postprandial conditions to evaluate the bioequivalence of the test and reference formulations in healthy participants.
Secondary Objective: To observe the safety of the test and reference formulations in healthy participants.
/ CompletedNot Applicable 盐酸氟桂利嗪胶囊在健康受试者中的人体生物等效性预试验
[Translation] Preliminary human bioequivalence study of flunarizine hydrochloride capsules in healthy subjects
以四川依科制药有限公司的盐酸氟桂利嗪胶囊(规格:5mg(以C26H26F2N2计))为受试制剂,以西安杨森制药有限公司持证的盐酸氟桂利嗪胶囊(规格:5mg(以C26H26F2N2计))为参比制剂,按生物等效性试验的有关规定,考察两制剂在健康人体内的生物等效性。
[Translation] Flunarizine hydrochloride capsules (5mg (C26H26F2N2)) from Sichuan Yike Pharmaceutical Co., Ltd. were used as the test formulation, and flunarizine hydrochloride capsules (5mg (C26H26F2N2)) from Xi'an Janssen Pharmaceutical Co., Ltd. were used as the reference formulation. The bioequivalence of the two formulations in healthy human subjects was investigated in accordance with the relevant regulations for bioequivalence testing.
100 Clinical Results associated with Sichuan Province Shuzhong Pharmacy Co., Ltd.
0 Patents (Medical) associated with Sichuan Province Shuzhong Pharmacy Co., Ltd.
100 Deals associated with Sichuan Province Shuzhong Pharmacy Co., Ltd.
100 Translational Medicine associated with Sichuan Province Shuzhong Pharmacy Co., Ltd.