Delving into the Latest Updates on Zhongshuai Pharmaceutical Sci & Tech Co., Ltd. with Synapse

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Disease Domain	Count

Nervous System Diseases	1
Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Small molecule drug	2

Top 5 Target	Count

CAs(Carbonic anhydrases)	1
DAT x NET	1

主要研究目的：研究餐后状态下单次口服受试制剂盐酸右哌甲酯片（规格：2.5mg，河南中帅药业有限公司生产）与参比制剂盐酸右哌甲酯片（Focalin®，规格：2.5mg，Mikart, LLC生产）在健康成年受试者体内的药代动力学参数，评价餐后状态口服两种制剂的生物等效性。次要研究目的：评估受试制剂盐酸右哌甲酯片（规格：2.5mg）和参比制剂盐酸右哌甲酯片（Focalin®，规格：2.5mg）在健康成年受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic parameters of the test preparation dexmethylphenidate hydrochloride tablets (specification: 2.5 mg, produced by Henan Zhongshuai Pharmaceutical Co., Ltd.) and the reference preparation dexmethylphenidate hydrochloride tablets (Focalin®, specification: 2.5 mg, produced by Mikart, LLC) in healthy adult subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. Secondary purpose of the study is to evaluate the safety of the test preparation dexmethylphenidate hydrochloride tablets (specification: 2.5 mg) and the reference preparation dexmethylphenidate hydrochloride tablets (Focalin®, specification: 2.5 mg) in healthy adult subjects.

Start Date07 Apr 2025

Sponsor / Collaborator

Henan Zhongshuai Pharmaceutical Co., Ltd.

CTR20250410

/ CompletedNot Applicable

评估盐酸右哌甲酯片在健康成年受试者空腹状态下的单中心、随机、开放、单剂量、两周期、两序列、交叉生物等效性研究

[Translation] A single-center, randomized, open-label, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the efficacy of dexmethylphenidate hydrochloride tablets in healthy adult subjects under the fasting state

主要研究目的：研究空腹状态下单次口服受试制剂盐酸右哌甲酯片（规格：2.5 mg，河南中帅药业有限公司生产）与参比制剂盐酸右哌甲酯片（Focalin®，规格：2.5 mg，Mikart, LLC生产）在健康成年受试者体内的药代动力学参数，评价空腹状态口服两种制剂的生物等效性。次要研究目的：评估受试制剂盐酸右哌甲酯片（规格：2.5 mg）和参比制剂盐酸右哌甲酯片（Focalin®，规格：2.5 mg）在健康成年受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic parameters of the test preparation dexmethylphenidate hydrochloride tablets (specification: 2.5 mg, produced by Henan Zhongshuai Pharmaceutical Co., Ltd.) and the reference preparation dexmethylphenidate hydrochloride tablets (Focalin®, specification: 2.5 mg, produced by Mikart, LLC) in healthy adult subjects after a single oral administration in the fasting state, and to evaluate the bioequivalence of the two preparations in the fasting state. Secondary purpose of the study: to evaluate the safety of the test preparation dexmethylphenidate hydrochloride tablets (specification: 2.5 mg) and the reference preparation dexmethylphenidate hydrochloride tablets (Focalin®, specification: 2.5 mg) in healthy adult subjects.

Start Date25 Feb 2025

Sponsor / Collaborator

Henan Zhongshuai Pharmaceutical Co., Ltd.

CTR20242191

/ CompletedNot Applicable

盐酸达泊西汀片在健康受试者中单中心、随机、开放、单剂量、两周期、双交叉餐后状态下的生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of dapoxetine hydrochloride tablets in healthy subjects under the fed state

主要研究目的：评价河南中帅医药科技股份有限公司研制的盐酸达泊西汀片与持证商为Berlin-Chemie AG，生产厂家为Menarini-Von Heyden GmbH的盐酸达泊西汀片餐后单次口服给药在中国健康男性成年受试者中的生物等效性。次要目的：评价受试制剂和参比制剂在中国健康男性成年受试者中的安全性。

[Translation]

Main study objectives: To evaluate the bioequivalence of dapoxetine hydrochloride tablets developed by Henan Zhongshuai Pharmaceutical Technology Co., Ltd. and dapoxetine hydrochloride tablets manufactured by Berlin-Chemie AG and Menarini-Von Heyden GmbH after a single oral administration in healthy male adult subjects in China. Secondary objectives: To evaluate the safety of the test formulation and the reference formulation in healthy male adult subjects in China.

Start Date28 Jun 2024

Sponsor / Collaborator

Zhongshuai Pharmaceutical Sci & Tech Co., Ltd.

100 Clinical Results associated with Zhongshuai Pharmaceutical Sci & Tech Co., Ltd.

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0 Patents (Medical) associated with Zhongshuai Pharmaceutical Sci & Tech Co., Ltd.

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100 Deals associated with Zhongshuai Pharmaceutical Sci & Tech Co., Ltd.

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100 Translational Medicine associated with Zhongshuai Pharmaceutical Sci & Tech Co., Ltd.

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Pipeline

Pipeline Snapshot as of 24 Aug 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Phase 3

1

Approved

Other

1

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Dexmethylphenidate Hydrochloride ( DAT x NET )	Attention Deficit Disorder With Hyperactivity More	Approved
Acetazolamide ( CAs )	Altitude Sickness More	Phase 3