Delving into the Latest Updates on Suzhou Homesun Pharmaceutical Co. Ltd. with Synapse

Overview

Tags

Neoplasms

Cardiovascular Diseases

Other Diseases

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

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Targets

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Disease Domain	Count

Neoplasms	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

α-adrenergic receptor(Alpha adrenergic receptor)	1

主要目的：研究空腹状态下单次口服受试制剂螺内酯片（规格：100mg；苏州弘森药业股份有限公司生产）与参比制剂螺内酯片（Aldactone®，规格：100mg；Pfizer Inc.持证）在健康成年受试者体内的药代动力学，评价空腹状态口服两种制剂的生物等效性。

[Translation]

Primary objective: To study the pharmacokinetics of a single oral dose of the test preparation, spironolactone tablets (specification: 100 mg; produced by Suzhou Hongsen Pharmaceutical Co., Ltd.) and the reference preparation, spironolactone tablets (Aldactone®, specification: 100 mg; certified by Pfizer Inc.) in healthy adult subjects in the fasting state, and to evaluate the bioequivalence of the two preparations in the fasting state.

Start Date23 Aug 2023

Sponsor / Collaborator

Suzhou Homesun Pharmaceutical Co. Ltd.

CTR20231617 / CompletedNot Applicable

随机、开放、单剂量、两制剂、两序列、自身交叉对照设计，评价中国健康受试者在空腹状态下单次口服螺内酯片后的生物等效性正式试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, self-crossover controlled study to evaluate the bioequivalence of spironolactone tablets in Chinese healthy subjects after a single oral dose in the fasting state

主要目的：以苏州弘森药业股份有限公司提供的螺内酯片受试制剂，按生物等效性试验的有关规定，与Pfizer Inc.持证的螺内酯片（商品名：Aldactone®，参比制剂）对比在健康人体内的吸收速度及吸收程度，考察两制剂的人体生物等效性。

[Translation]

Main objective: To compare the absorption rate and extent of the test preparation of spironolactone tablets provided by Suzhou Hongsen Pharmaceutical Co., Ltd. with that of spironolactone tablets (trade name: Aldactone®, reference preparation) certified by Pfizer Inc. in healthy humans according to the relevant provisions of bioequivalence studies, and to investigate the bioequivalence of the two preparations in humans.

Start Date12 May 2023

Sponsor / Collaborator

Suzhou Homesun Pharmaceutical Co. Ltd.

CTR20223402 / CompletedNot Applicable

随机、开放、单剂量、两制剂、两序列、自身交叉对照设计，评价中国健康受试者单次口服螺内酯片后的生物等效性正式试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, self-crossover controlled study to evaluate the bioequivalence of spironolactone tablets after a single oral dose in healthy Chinese subjects

以苏州弘森药业股份有限公司提供的螺内酯片受试制剂，按生物等效性试验的有关规定，与Pfizer Inc.持证的螺内酯片（商品名：Aldactone®，参比制剂）对比在健康人体内的吸收速度及吸收程度，考察两制剂的人体生物等效性。

[Translation]

The absorption rate and extent of the test preparation of spironolactone tablets provided by Suzhou Hongsen Pharmaceutical Co., Ltd. (trade name: Aldactone®, reference preparation) in healthy human bodies were compared with those of spironolactone tablets (trade name: Aldactone®, reference preparation) certified by Pfizer Inc. in accordance with the relevant provisions of the bioequivalence test, and the bioequivalence of the two preparations in humans was investigated.

Start Date06 Mar 2023

Sponsor / Collaborator

Suzhou Homesun Pharmaceutical Co. Ltd.

100 Clinical Results associated with Suzhou Homesun Pharmaceutical Co. Ltd.

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0 Patents (Medical) associated with Suzhou Homesun Pharmaceutical Co. Ltd.

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100 Deals associated with Suzhou Homesun Pharmaceutical Co. Ltd.

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100 Translational Medicine associated with Suzhou Homesun Pharmaceutical Co. Ltd.

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Pipeline

Pipeline Snapshot as of 23 Nov 2024

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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