[Translation] A randomized, open-label, two-sequence, two-period, crossover bioequivalence trial of evokinetic tablets in healthy subjects under fasting and postprandial conditions.

主要目的：研究空腹及餐后状态下，单次口服依伏卡塞片受试制剂（规格：2mg，扬子江药业集团南京海陵药业有限公司）与参比制剂（商品名：ORKEDIA®，规格：2mg，协和麒麟株式会社）在健康受试者中的药代动力学行为，评价两制剂的生物等效性。次要目的：评价受试制剂依伏卡塞片和参比制剂ORKEDIA®在健康受试者中的安全性。

[Translation]

Primary objective: To investigate the pharmacokinetic behavior of the test formulation (2 mg, Nanjing Hailing Pharmaceutical Co., Ltd., Yangtze River Pharmaceutical Group) and the reference formulation (ORKEDIA®, 2 mg, Kyowa Kirin Co., Ltd.) after a single oral dose in healthy subjects under fasting and postprandial conditions, and to evaluate the bioequivalence of the two formulations. Secondary objective: To evaluate the safety of the test formulation evokase and the reference formulation ORKEDIA® in healthy subjects.

Start Date29 Nov 2025

Sponsor / Collaborator

Yangtze River Pharmaceutical Gp Nanjing Hailing Pharm Co. Ltd.

CTR20253103

/ CompletedNot Applicable

依伏卡塞片在健康受试者中空腹和餐后状态下随机、开放、两序列、两周期、交叉生物等效性预试验

[Translation] A randomized, open-label, two-sequence, two-period, crossover bioequivalence pilot study of ivocate tablets in healthy subjects under fasting and fed conditions

主要目的：研究空腹及餐后状态下，单次口服依伏卡塞片受试制剂（规格：2mg，扬子江药业集团南京海陵药业有限公司）与参比制剂（商品名：ORKEDIA®，规格：2mg，协和麒麟株式会社）在健康受试者中的药代动力学行为，评价两制剂的生物等效性趋势，为正式试验提供依据。次要目的：评价受试制剂依伏卡塞片和参比制剂ORKEDIA®在健康受试者中的安全性。

[Translation]

Primary Objective: To investigate the pharmacokinetic behavior of a single oral dose of the test formulation of ivocasert tablets (strength: 2 mg, Yangtze River Pharmaceutical Group Nanjing Hailing Pharmaceutical Co., Ltd.) and a reference formulation (trade name: ORKEDIA®, strength: 2 mg, Kyowa Kirin Co., Ltd.) in healthy volunteers, both in the fasting and fed state, to evaluate the bioequivalence trend of the two formulations and provide a basis for a formal trial. Secondary Objective: To evaluate the safety of the test formulation of ivocasert tablets and the reference formulation of ORKEDIA® in healthy volunteers.

Start Date28 Aug 2025

Sponsor / Collaborator

Yangtze River Pharmaceutical Gp Nanjing Hailing Pharm Co. Ltd.

CTR20233402

/ CompletedNot Applicable

布瑞哌唑片在健康受试者中空腹及餐后状态下的随机、开放、两周期、双交叉生物等效性临床试验

[Translation] A randomized, open-label, two-period, double-crossover bioequivalence clinical trial of brepazole tablets in healthy subjects under fasting and fed conditions

主要目的：研究空腹及餐后状态下，单次口服布瑞哌唑片受试制剂（规格：2mg，扬子江药业集团南京海陵药业有限公司）与参比制剂（REXULTI®，规格：2mg，Otsuka Pharmaceutical Co., Ltd.）在健康受试者中的药代动力学行为，评价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（商品名：REXULTI®）在健康受试者中的安全性。

[Translation]

Primary objective: To study the pharmacokinetic behavior of the test formulation of brexpiprazole tablets (specification: 2 mg, Nanjing Hailing Pharmaceutical Co., Ltd., Yangtze River Pharmaceutical Group) and the reference formulation (REXULTI®, specification: 2 mg, Otsuka Pharmaceutical Co., Ltd.) in healthy subjects after a single oral administration under fasting and postprandial conditions, and to evaluate the bioequivalence of the two formulations. Secondary objective: To evaluate the safety of the test formulation and the reference formulation (trade name: REXULTI®) in healthy subjects.

Start Date16 Nov 2023

Sponsor / Collaborator

Yangtze River Pharmaceutical Gp Nanjing Hailing Pharm Co. Ltd.

100 Clinical Results associated with Yangtze River Pharmaceutical Gp Nanjing Hailing Pharm Co. Ltd.

0 Patents (Medical) associated with Yangtze River Pharmaceutical Gp Nanjing Hailing Pharm Co. Ltd.

100 Deals associated with Yangtze River Pharmaceutical Gp Nanjing Hailing Pharm Co. Ltd.

100 Translational Medicine associated with Yangtze River Pharmaceutical Gp Nanjing Hailing Pharm Co. Ltd.

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