[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence trial evaluating the investigational formulation oseltamivir phosphate capsules (75 mg) and the reference formulation oseltamivir phosphate capsules (Tamiflu®/Tamiflu®, 75 mg) in healthy adult participants in fasting condition.

主要研究目的：研究空腹下单次口服受试制剂磷酸奥司他韦胶囊(规格：75mg；重庆科瑞南海制药有限责任公司生产)与参比制剂磷酸奥司他韦胶囊(达菲®/Tamiflu®：规格：75mg; Delpharm Milano S.r.l生产)在健康成年参与者体内的药代动力学，评价空腹状态下口服两种制剂的生物等效性。次要研究目的：评估受试制剂磷酸奥司他韦胶囊(规格：75 mg)和参比制剂磷酸奥司他韦胶囊(达菲®/Tamiflu®，规格：75 mg)在健康参与者中的安全性。

[Translation]

Primary objective: To investigate the pharmacokinetics of a single oral dose of the test formulation oseltamivir phosphate capsules (75 mg; manufactured by Chongqing Kerui Nanhai Pharmaceutical Co., Ltd.) and the reference formulation oseltamivir phosphate capsules (Tamiflu®: 75 mg; manufactured by Delpharm Milano S.r.l.) in healthy adult participants under fasting conditions, and to evaluate the bioequivalence of the two formulations under fasting conditions. Secondary objective: To evaluate the safety of the test formulation oseltamivir phosphate capsules (75 mg) and the reference formulation oseltamivir phosphate capsules (Tamiflu®, 75 mg) in healthy participants.

Start Date29 Mar 2026

Sponsor / Collaborator

Chongqingkeruinanhai Pharmacy Co., Ltd.

CTR20244527

/ CompletedNot Applicable

重庆科瑞南海制药有限责任公司研制的达格列净片（10 mg）与AstraZeneca AB持证的达格列净片（安达唐®/FORXIGA®，10 mg）在中国健康受试者中进行的随机、开放、单次给药、两周期、双交叉设计的空腹及餐后状态下的生物等效性研究

[Translation] A randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of dapagliflozin tablets (10 mg) developed by Chongqing Kerui Nanhai Pharmaceutical Co., Ltd. and dapagliflozin tablets (Andatang®/FORXIGA®, 10 mg) licensed by AstraZeneca AB in healthy Chinese subjects under fasting and fed conditions

以重庆科瑞南海制药有限责任公司研制的达格列净片（规格：10 mg）为受试制剂，AstraZeneca AB持证的达格列净片（商品名：安达唐®/FORXIGA®，规格：10 mg）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。

[Translation]

The dapagliflozin tablets (specification: 10 mg) developed by Chongqing Kerui Nanhai Pharmaceutical Co., Ltd. were used as the test preparation, and the dapagliflozin tablets (trade name: Andatang®/FORXIGA®, specification: 10 mg) licensed by AstraZeneca AB were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Start Date24 Dec 2024

Sponsor / Collaborator

Chongqingkeruinanhai Pharmacy Co., Ltd.

CTR20191699

/ Completed

在健康志愿者中单中心、开放、均衡、随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性试验

[Translation] A single-center, open-label, balanced, randomized, single-dose, two-period, double-crossover bioequivalence study in healthy volunteers in the fasting and fed states

主要目的：比较空腹及餐后给药条件下，重庆科瑞南海制药有限责任公司提供的盐酸二甲双胍缓释片（0.5g）与BRISTOL MYERS SQUIBB CO.生产的盐酸二甲双胍缓释片（0.5g，商品名：GLUCOPHAGE XR®）在健康成年人群中吸收程度和速度的差异，评价其生物等效性。次要目的：评价空腹及餐后给药条件下，重庆科瑞南海制药有限责任公司提供的盐酸二甲双胍缓释片（0.5g）的安全性。

[Translation]

Primary objective: To compare the differences in absorption extent and rate of metformin hydrochloride sustained-release tablets (0.5g) provided by Chongqing Kerui Nanhai Pharmaceutical Co., Ltd. and metformin hydrochloride sustained-release tablets (0.5g, trade name: GLUCOPHAGE XR®) produced by BRISTOL MYERS SQUIBB CO. in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence. Secondary objective: To evaluate the safety of metformin hydrochloride sustained-release tablets (0.5g) provided by Chongqing Kerui Nanhai Pharmaceutical Co., Ltd. under fasting and postprandial administration conditions.

Start Date20 Aug 2019

Sponsor / Collaborator

Chongqingkeruinanhai Pharmacy Co., Ltd.

100 Clinical Results associated with Chongqingkeruinanhai Pharmacy Co., Ltd.

0 Patents (Medical) associated with Chongqingkeruinanhai Pharmacy Co., Ltd.

100 Deals associated with Chongqingkeruinanhai Pharmacy Co., Ltd.

100 Translational Medicine associated with Chongqingkeruinanhai Pharmacy Co., Ltd.

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