Target- |
MechanismImmunomodulators |
|
|
|
Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.China |
First Approval Date01 Jan 1995 |
/ Active, not recruitingNot Applicable [Translation] Bioequivalence study of tacrolimus extended-release capsules in healthy participants
主要目的:采用单中心、随机、开放、单剂量、两制剂、两序列、四周期、完全重复交叉试验
设计评价国药集团川抗制药有限公司生产的他克莫司缓释胶囊(规格:1mg)与 Astellas Pharma Europe B.V.持证的他克莫司缓释胶囊(商品名:新普乐可复®,规格:1mg)的药动学参数,评价参比制剂
与受试制剂在空腹和餐后条件下的人体生物等效性。
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: To evaluate the pharmacokinetic parameters of tacrolimus extended-release capsules (1 mg) manufactured by Sinopharm Sichuan Kang Pharmaceutical Co., Ltd. and tacrolimus extended-release capsules (trade name: Xinpulekefu®, 1 mg) certified by Astellas Pharma Europe B.V., using a single-center, randomized, open-label, single-dose, two-formulation, two-sequence, four-period, fully replicated crossover trial design, and to assess the bioequivalence of the reference formulation and the test formulation in humans under fasting and postprandial conditions.
Secondary Objective: To observe the safety of the test and reference formulations in healthy participants.
/ CompletedNot Applicable [Translation] Bioequivalence trial of Ailamode tablets in healthy participants
主要目的:采用单中心、随机、开放、单剂量、两制剂、两周期、自身交叉给药设计评价国药
集团川抗制药有限公司生产的艾拉莫德片(规格:25mg)与海南先声药业有限公司持证的艾拉莫德片(商品名:艾得辛®,规格:25mg)的药动学参数,评价参比制剂与受试制剂在空腹和餐后条件下的人体生物等效性。 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: To evaluate the pharmacokinetic parameters of Ailamod tablets (25mg) manufactured by Sinopharm Sichuan Kang Pharmaceutical Co., Ltd. and Ailamod tablets (trade name: Aidexin®, 25mg) certified by Hainan Xiansheng Pharmaceutical Co., Ltd., using a single-center, randomized, open-label, single-dose, two-formulation, two-period, self-crossover design, and to evaluate the bioequivalence of the reference and test formulations in humans under fasting and postprandial conditions. Secondary objective: To observe the safety of the test and reference formulations in healthy participants.
/ CompletedNot Applicable [Translation] Bioequivalence study of iguratimod tablets in healthy participants
主要目的:采用单中心、随机、开放、单剂量、两制剂、两周期、自身交叉给药设计评价国药集团川抗制药有限公司生产的艾拉莫德片(规格:25mg)与海南先声药业有限公司持证的艾拉莫德片(商品名:艾得辛®,规格:25mg)的药动学参数,评价参比制剂与受试制剂在空腹和餐后条件下的人体生物等效性。
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: To evaluate the pharmacokinetic parameters of iguratimod tablets (25 mg) produced by Sinopharm Sichuan Kang Pharmaceutical Co., Ltd. and iguratimod tablets (25 mg, trade name: Edixin®) produced by Hainan Xiansheng Pharmaceutical Co., Ltd. using a single-center, randomized, open-label, single-dose, two-formulation, two-period, self-crossover design. The aim was to assess the bioequivalence of the reference formulation and the test formulation under fasting and fed conditions.
Secondary Objective: To observe the safety of the test and reference formulations in healthy volunteers.
100 Clinical Results associated with Sinopharm Chuankang Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Sinopharm Chuankang Pharmaceutical Co. Ltd.
RSC advancesQ3 · CHEMISTRY
Insights into the interaction mechanism between tiagabine hydrochloride and two serum albumins
Q3 · CHEMISTRY
ArticleOA
Author: Peng, Xilin ; Lin, Xiang ; Zhuo, Weiling
Tiagabine could bind in Sudlow site II of HSA and BSA.
100 Deals associated with Sinopharm Chuankang Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Sinopharm Chuankang Pharmaceutical Co. Ltd.