[Translation] Bioequivalence studies of dapagliflozin tablets in healthy participants under fasting and postprandial conditions, using a single-dose, randomized, open-label, two-period, two-sequence, two-crossover design.

主要目的：本研究以江西制药有限责任公司持证的达格列净片为受试制剂，阿斯利康药业（中国）有限公司持证的达格列净片为参比制剂，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参与者中的安全性。

[Translation]

Primary Objective: This study used dapagliflozin tablets (licensed by Jiangxi Pharmaceutical Co., Ltd.) as the test formulation and dapagliflozin tablets (licensed by AstraZeneca Pharmaceuticals (China) Co., Ltd.) as the reference formulation to conduct a human bioequivalence study under fasting and postprandial conditions to evaluate the bioequivalence of the test and reference formulations in healthy subjects. Secondary Objective: To observe the safety of the test and reference formulations in healthy participants.

Start Date18 Apr 2026

Sponsor / Collaborator

Jiangxi Pharmaceutical Co., Ltd.

CTR20212716

/ CompletedNot Applicable

阿托伐他汀钙片在中国成年健康受试者中的一项随机、开放、空腹和餐后单次给药、两制剂、三序列、三周期交叉的生物等效性试验

[Translation] A randomized, open-label, single-dose, fasting and fed, two-formulation, three-sequence, three-period crossover bioequivalence study of atorvastatin calcium tablets in healthy adult Chinese subjects

主要目的：考察单次口服20mg（空腹/餐后）受试制剂阿托伐他汀钙片（规格：20mg/片，江西制药有限责任公司生产）与参比制剂阿托伐他汀钙片（商品名：立普妥®，规格：20mg/片，辉瑞制药有限公司生产）在中国成年健康受试者体内的药代动力学特征，评价空腹与餐后状态分别口服两种制剂的生物等效性。次要目的：评价受试制剂和参比制剂单次口服20mg（空腹/餐后）在中国成年健康受试者中的安全性。

[Translation]

Primary objective: To investigate the pharmacokinetic characteristics of a single oral dose of 20 mg (fasting/after meal) of the test preparation atorvastatin calcium tablets (specification: 20 mg/tablet, produced by Jiangxi Pharmaceutical Co., Ltd.) and the reference preparation atorvastatin calcium tablets (trade name: Lipitor®, specification: 20 mg/tablet, produced by Pfizer Pharmaceuticals Co., Ltd.) in healthy adult Chinese subjects, and to evaluate the bioequivalence of the two preparations in fasting and after meal states. Secondary objective: To evaluate the safety of a single oral dose of 20 mg (fasting/after meal) of the test preparation and the reference preparation in healthy adult Chinese subjects.

Start Date22 Nov 2021

Sponsor / Collaborator

Jiangxi Pharmaceutical Co., Ltd.

CTR20211241

/ CompletedNot Applicable

健康男性受试者在空腹条件下口服盐酸达泊西汀片30mg受试制剂和参比制剂的随机、开放、单剂量、双周期交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-period crossover bioequivalence study of the test and reference formulations of dapoxetine hydrochloride tablets 30 mg orally administered to healthy male subjects under fasting conditions

评价健康成年男性受试者在空腹条件下单剂量服用江西制药有限责任公司持有的盐酸达泊西汀片30mg（受试制剂）与Berlin-Chemie AG持有的必利劲® 30mg（参比制剂）的生物等效性以及安全性。

[Translation]

To evaluate the bioequivalence and safety of a single dose of dapoxetine hydrochloride tablets 30 mg (test preparation) produced by Jiangxi Pharmaceutical Co., Ltd. and Priligy® 30 mg (reference preparation) produced by Berlin-Chemie AG in healthy adult male subjects under fasting conditions.

Start Date12 Aug 2021

Sponsor / Collaborator

Jiangxi Pharmaceutical Co., Ltd.

100 Clinical Results associated with Jiangxi Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Jiangxi Pharmaceutical Co., Ltd.

100 Deals associated with Jiangxi Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Jiangxi Pharmaceutical Co., Ltd.

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