Delving into the Latest Updates on Hangzhou Zhuyangxin Pharmaceutical Co. Ltd. with Synapse

Overview

Tags

Congenital Disorders

Immune System Diseases

Endocrinology and Metabolic Disease

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Endocrinology and Metabolic Disease	1
Immune System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

XO(Xanthine dehydrogenase)	1

主要目的：以大黄酸（双醋瑞因的活性代谢产物）的主要药代动力学参数（AUC和Cmax）为生物等效性的评价指标，在中国健康受试者空腹和餐后状态下评估受试制剂（杭州朱养心药业有限公司申报的双醋瑞因胶囊，规格：50mg）和参比制剂（TRB Pharma S.A持证的双醋瑞因胶囊，规格：50mg；商品名：安必丁®ARTRODAR®）的生物等效性。次要目的：观察空腹和餐后状态下受试制剂和参比制剂的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the test preparation (Diacerein Capsules declared by Hangzhou Zhuyangxin Pharmaceutical Co., Ltd., specification: 50 mg) and the reference preparation (Diacerein Capsules certified by TRB Pharma S.A., specification: 50 mg; trade name: ARTRODAR®) in Chinese healthy subjects under fasting and fed conditions, using the main pharmacokinetic parameters (AUC and Cmax) of rhein (active metabolite of diacerein) as bioequivalence evaluation indicators. Secondary objective: To observe the safety of the test preparation and the reference preparation under fasting and fed conditions.

Start Date04 Dec 2024

Sponsor / Collaborator

Hangzhou Zhuyangxin Pharmaceutical Co. Ltd.

CTR20244411

/ Active, not recruitingNot Applicable

中国健康受试者涂抹双氯芬酸二乙胺乳胶剂的单中心、随机、开放、两制剂、单次给药、三序列、三周期，部分重复交叉设计生物等效性试验

[Translation] A single-center, randomized, open-label, two-dose, single-dose, three-sequence, three-period, partially repeated crossover bioequivalence study of diclofenac diethylamine emulsion in healthy Chinese subjects

主要研究目的：研究空腹状态下单次涂抹受试制剂双氯芬酸二乙胺乳胶剂（规格：1%（20g:0.2g，以C14H10Cl2NNaO2计），杭州朱养心药业有限公司生产）与参比制剂双氯芬酸二乙胺乳胶剂（商品名：扶他林®，规格：1%（20g:0.2g，以双氯芬酸钠计），GSK Consumer Healthcare SARL生产）在中国健康受试者中的药代动力学，评价两种制剂的生物等效性。次要研究目的：评价中国健康受试者空腹单次涂抹受试制剂（T）双氯芬酸二乙胺乳胶剂和参比制剂（R）双氯芬酸二乙胺乳胶剂（扶他林®）后的安全性。

[Translation]

Main study objectives: To study the pharmacokinetics of the test preparation diclofenac diethylamine emulsion (specification: 1% (20g:0.2g, calculated as C14H10Cl2NNaO2), produced by Hangzhou Zhuyangxin Pharmaceutical Co., Ltd.) and the reference preparation diclofenac diethylamine emulsion (trade name: Voltaren®, specification: 1% (20g:0.2g, calculated as diclofenac sodium), produced by GSK Consumer Healthcare SARL) in healthy Chinese subjects under fasting state, and to evaluate the bioequivalence of the two preparations. Secondary study objectives: To evaluate the safety of the test preparation (T) diclofenac diethylamine emulsion and the reference preparation (R) diclofenac diethylamine emulsion (Voltaren®) after a single fasting application in healthy Chinese subjects.

Start Date27 Nov 2024

Sponsor / Collaborator

Hangzhou Zhuyangxin Pharmaceutical Co. Ltd.

CTR20241601

/ CompletedNot Applicable

格拉司琼透皮贴片在中国健康受试者外用条件下的单中心、随机、开放、两制剂、两周期、两序列、单次给药、双交叉生物等效性研究

[Translation] A single-center, randomized, open-label, two-formulation, two-period, two-sequence, single-dose, double-crossover bioequivalence study of granisetron transdermal patch in Chinese healthy volunteers under topical conditions

主要目的：以格拉司琼的主要药代动力学参数（AUC和Cmax）为生物等效性的评价指标，在中国健康受试者外用条件下评估受试制剂（杭州朱养心药业有限公司生产的格拉司琼透皮贴片，规格34.3mg/52cm2）和参比制剂（Kyowa Kirin Inc.持证的格拉司琼透皮贴片，规格34.3mg/52cm2，商品名：善可舒®）的生物等效性。次要目的：观察外用条件下受试制剂和参比制剂的黏附性、刺激性和安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the test preparation (granisetron transdermal patch produced by Hangzhou Zhuyangxin Pharmaceutical Co., Ltd., specification 34.3mg/52cm2) and the reference preparation (granisetron transdermal patch certified by Kyowa Kirin Inc., specification 34.3mg/52cm2, trade name: Sancuso®) under topical conditions in Chinese healthy subjects using the main pharmacokinetic parameters (AUC and Cmax) of granisetron as bioequivalence evaluation indicators. Secondary objective: To observe the adhesion, irritation and safety of the test preparation and the reference preparation under topical conditions.

Start Date10 Apr 2024

Sponsor / Collaborator

Hangzhou Zhuyangxin Pharmaceutical Co. Ltd.

100 Clinical Results associated with Hangzhou Zhuyangxin Pharmaceutical Co. Ltd.

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0 Patents (Medical) associated with Hangzhou Zhuyangxin Pharmaceutical Co. Ltd.

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1

Literatures (Medical) associated with Hangzhou Zhuyangxin Pharmaceutical Co. Ltd.

Zhongguo Yaofang

Clinical research progress in selective xanthine oxidase inhibitor of febuxostat

Author: Tang, Jian-fei ; He, Hai-zhen ; Shen, Ru-jie ; Yao, Cheng-e ; Li, Yue-dong ; Zhao, Fu-bin

A review with 21 referencesThe aim is to summarize clin. research progress in selective xanthine oxidase inhibitor of febuxosta.By literature review in recent years, the literatures are classified.As a selective xanthine oxidase inhibitor of febuxostat, it has good efficacy and safety in gout.

100 Deals associated with Hangzhou Zhuyangxin Pharmaceutical Co. Ltd.

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100 Translational Medicine associated with Hangzhou Zhuyangxin Pharmaceutical Co. Ltd.

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Pipeline

Pipeline Snapshot as of 31 Jan 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

Approved

1

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