[Translation] A randomized, open-label, single-dose, fasting two-dose, two-sequence, two-period crossover and fed two-dose, three-sequence, three-period partially repeated crossover bioequivalence study of Cinipride Tartrate Tablets in healthy Chinese adult subjects

主要研究目的：考察空腹/餐后单次口服受试制剂酒石酸西尼必利片（规格：1 mg，江苏永安制药有限公司生产）与参比制剂酒石酸西尼必利片（商品名：Cidine（希笛尼）®，规格：1 mg，Almirall, S.A.持证），在中国成年健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性。次要研究目的：评价空腹/餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。

[Translation]

Main study objectives: To investigate the relative bioavailability of the test preparation Cinipride Tartrate Tablets (Specification: 1 mg, produced by Jiangsu Yongan Pharmaceutical Co., Ltd.) and the reference preparation Cinipride Tartrate Tablets (trade name: Cidine®, specification: 1 mg, licensed by Almirall, S.A.) in healthy Chinese adults after a single oral administration on an empty stomach/after a meal, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations. Secondary study objectives: To evaluate the safety of the test preparation and the reference preparation in healthy Chinese adults after a single oral administration on an empty stomach/after a meal.

Start Date-

Sponsor / Collaborator

Jiangsu Yong'an Pharmaceutical Co Ltd.

CTR20244713

/ Not yet recruitingNot Applicable

艾拉莫德片在中国成年健康受试者中的一项单中心、随机、开放、空腹和餐后单次给药、两制剂、两序列、两周期交叉的生物等效性研究

[Translation] A single-center, randomized, open-label, single-dose, fasting and postprandial, two-formulation, two-sequence, two-period crossover bioequivalence study of iguratimod tablets in healthy adult Chinese subjects

主要研究目的：考察单次单剂量口服（空腹/餐后）受试制剂艾拉莫德片（规格：25mg，江苏永安制药有限公司生产）与参比制剂艾拉莫德片（商品名：艾得辛®，规格：25mg，海南先声药业有限公司持证生产），在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为受试制剂艾拉莫德片的申报及临床用药提供参考依据。次要研究目的：评价空腹、餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。

[Translation]

The main purpose of the study is to investigate the relative bioavailability of the test preparation Iguratimod tablets (specification: 25 mg, produced by Jiangsu Yongan Pharmaceutical Co., Ltd.) and the reference preparation Iguratimod tablets (trade name: Edesin®, specification: 25 mg, produced by Hainan Xiansheng Pharmaceutical Co., Ltd. with a license) in healthy Chinese subjects after a single oral dose (fasting/postprandial), analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the test preparation Iguratimod tablets. The secondary purpose of the study is to evaluate the safety of the test preparation and the reference preparation in Chinese healthy adult subjects after a single oral dose (fasting/postprandial).

Start Date-

Sponsor / Collaborator

Jiangsu Yong'an Pharmaceutical Co Ltd.

CTR20243513

/ CompletedNot Applicable

双醋瑞因胶囊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、两序列、两周期交叉的生物等效性研究

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

主要研究目的：考察空腹/餐后单次口服受试制剂双醋瑞因胶囊（规格：50 mg，江苏永安制药有限公司生产）与参比制剂双醋瑞因胶囊（商品名：安必丁®，规格：50 mg，TRB Pharma S.A.持证），在中国成年健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性。次要研究目的：评价空腹/餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。

[Translation]

Main study objectives: To investigate the relative bioavailability of the test preparation Diacerein Capsules (specification: 50 mg, produced by Jiangsu Yongan Pharmaceutical Co., Ltd.) and the reference preparation Diacerein Capsules (trade name: Ambide®, specification: 50 mg, licensed by TRB Pharma S.A.) in healthy Chinese adults after a single oral administration on an empty stomach/after a meal, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations. Secondary study objectives: To evaluate the safety of the test preparation and the reference preparation in healthy Chinese adults after a single oral administration on an empty stomach/after a meal.

Start Date14 Oct 2024

Sponsor / Collaborator

Jiangsu Yong'an Pharmaceutical Co Ltd.

100 Clinical Results associated with Jiangsu Yong'an Pharmaceutical Co Ltd.

0 Patents (Medical) associated with Jiangsu Yong'an Pharmaceutical Co Ltd.

100 Deals associated with Jiangsu Yong'an Pharmaceutical Co Ltd.

100 Translational Medicine associated with Jiangsu Yong'an Pharmaceutical Co Ltd.

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