Delving into the Latest Updates on Zhongfu Pharmaceutical Co., Ltd. with Synapse

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Cardiovascular Diseases

Small molecule drug

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Small molecule drug	1

1主要研究目的以中孚药业股份有限公司生产的卡托普利片为受试制剂，以アルフレッサファーマ株式会社生产的卡托普利片(商品名：CAPTORIL®)为参比制剂，按生物等效性试验的相关规定，比较卡托普利片在中国健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。 2次要研究目的评价中国健康受试者单次空腹口服卡托普利片受试制剂和参比制剂后的安全性。

[Translation]

1Main study objectives Captopril tablets produced by Zhongfu Pharmaceutical Co., Ltd. were used as the test preparation, and Captopril tablets (trade name: CAPTORIL®) produced by Alfred Pharmaceuticals Co., Ltd. were used as the reference preparation. According to the relevant provisions of the bioequivalence test, the pharmacokinetic behavior of Captopril tablets in healthy Chinese subjects was compared to evaluate the bioequivalence of the two preparations. 2Secondary study objectives Evaluate the safety of the test preparation and reference preparation of Captopril tablets after a single oral administration on an empty stomach in healthy Chinese subjects.

Start Date27 Aug 2021

Sponsor / Collaborator

Zhongfu Pharmaceutical Co., Ltd.

CTR20171364

/ TerminatedNot Applicable

卡托普利片在健康受试者中随机、开放、单剂量、双周期、双交叉空腹状态下的生物等效性试验

[Translation] A randomized, open-label, single-dose, two-period, double-crossover bioequivalence study of captopril tablets in healthy subjects under fasting conditions

以中孚药业股份有限公司提供的卡托普利片为受试制剂，按生物等效性试验的有关规定，与第一三共エスファ株式会社生产的卡托普利片（商品名：CAPTORIL®，参比制剂）对比在健康人体内的相对生物利用度，考察两制剂的人体生物等效性。

[Translation]

Captopril tablets provided by Zhongfu Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of the bioequivalence study, the relative bioavailability in healthy humans was compared with that of Captopril tablets produced by Daiichi Sankyo Esfa Co., Ltd. (trade name: CAPTORIL®, reference preparation) to investigate the bioequivalence of the two preparations in humans.

Start Date11 Dec 2017

Sponsor / Collaborator

Zhongfu Pharmaceutical Co., Ltd.

CTR20244259

/ Not yet recruitingNot Applicable

尼莫地平片（30mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of nimodipine tablets (30 mg) in Chinese healthy subjects under fasting and fed conditions

主要研究目的：按有关生物等效性试验的规定，选择拜耳医药保健有限公司为持证商的尼莫地平片（商品名：尼膜同®，规格：30mg）为参比制剂，对中孚药业股份有限公司持证、兰西哈三联制药有限公司生产的受试制剂尼莫地平片（规格：30mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，比较两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂尼莫地平片（规格：30mg）和参比制剂尼莫地平片（商品名：尼膜同®，规格：30mg）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, nimodipine tablets (trade name: Nimotop®, specification: 30mg) with Bayer HealthCare Co., Ltd. as the licensee were selected as the reference preparation, and the test preparation nimodipine tablets (specification: 30mg) licensed by Zhongfu Pharmaceutical Co., Ltd. and produced by Lanxiha Sanlian Pharmaceutical Co., Ltd. were tested for fasting and postprandial administration in humans, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to compare the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation nimodipine tablets (specification: 30mg) and the reference preparation nimodipine tablets (trade name: Nimotop®, specification: 30mg) by healthy volunteers.

Start Date-

Sponsor / Collaborator

Zhongfu Pharmaceutical Co., Ltd.

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

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

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100 Deals associated with Zhongfu Pharmaceutical Co., Ltd.

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

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Pipeline

Pipeline Snapshot as of 02 Feb 2026

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

Approved

1

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