Delving into the Latest Updates on Zhejiang Dier Medicine Industry Co. Ltd. with Synapse

Overview

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Infectious Diseases

Small molecule drug

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Technology Platform

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Disease Domain	Count

Infectious Diseases	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

Bacterial DNA gyrase x Topoisomerase IV	1

以浙江迪耳药业有限公司生产的双氯芬酸钠缓释片（规格：0.1 g）为受试制剂，以Novartis Pharma Schweiz AG持证的双氯芬酸钠缓释片（商品名：Voltaren®，规格：0.1 g）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性；同时评价两种制剂在健康人体中的安全性和耐受性。

[Translation]

Diclofenac sodium sustained-release tablets (specification: 0.1 g) produced by Zhejiang Deer Pharmaceutical Co., Ltd. were used as the test preparation, and diclofenac sodium sustained-release tablets (trade name: Voltaren®, specification: 0.1 g) certified by Novartis Pharma Schweiz AG were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent; at the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Start Date-

Sponsor / Collaborator

Zhejiang Dier Medicine Industry Co. Ltd.

CTR20243162

/ CompletedNot Applicable

双氯芬酸钠缓释片在中国健康受试者中单中心、随机、开放、两制剂、空腹/餐后、单次给药、两序列、四周期、完全重复交叉设计的生物等效性研究

[Translation] A single-center, randomized, open-label, two-dose, fasting/fed, single-dose, two-sequence, four-period, completely repeated crossover bioequivalence study of diclofenac sodium extended-release tablets in Chinese healthy subjects

以浙江迪耳药业有限公司生产的双氯芬酸钠缓释片（规格：0.1 g）为受试制剂，以Novartis Pharma Schweiz AG持证的双氯芬酸钠缓释片（商品名：Voltaren®Retard，规格：0.1 g）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。同时评价两种制剂在健康人体中的安全性和耐受性。

[Translation]

Diclofenac sodium sustained-release tablets (specification: 0.1 g) produced by Zhejiang Deer Pharmaceutical Co., Ltd. were used as the test preparation, and diclofenac sodium sustained-release tablets (trade name: Voltaren® Retard, specification: 0.1 g) certified by Novartis Pharma Schweiz AG were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Start Date05 Sep 2024

Sponsor / Collaborator

Zhejiang Dier Medicine Industry Co. Ltd.

CTR20202674

/ CompletedPhase 1

双氯芬酸钠缓释片人体生物等效性预试验

[Translation] Preliminary study on bioequivalence of diclofenac sodium sustained-release tablets in healthy volunteers

主要目的：以中国健康受试者为对象，考察浙江迪耳药业有限公司研制的双氯芬酸钠缓释片（受试制剂，规格：0.1g/片）与Novartis Pharma GmbH生产的双氯酚酸钠缓释片（参比制剂，VOLTAREN 规格：0.1g/片）的药代动力学特征，进行空腹和餐后条件下单次给药（0.1g）的人体生物等效性预试验，验证采血时间、采血量、药物浓度分析方法等设计的合理性，为正式试验提供依据。次要目的：观察受试制剂与参比制剂在健康受试者中服药后的安全性。

[Translation]

Main purpose: To investigate the pharmacokinetic characteristics of diclofenac sodium sustained-release tablets (test preparation, specification: 0.1g/tablet) developed by Zhejiang Deer Pharmaceutical Co., Ltd. and diclofenac sodium sustained-release tablets (reference preparation, VOLTAREN specification: 0.1g/tablet) produced by Novartis Pharma GmbH using Chinese healthy subjects as subjects, to conduct a preliminary human bioequivalence study of a single dose (0.1g) under fasting and postprandial conditions, to verify the rationality of the design of blood collection time, blood collection volume, drug concentration analysis method, etc., to provide a basis for formal trials. Secondary purpose: To observe the safety of the test preparation and the reference preparation after taking the medicine in healthy subjects.

Start Date24 Oct 2020

Sponsor / Collaborator

Zhejiang Dier Medicine Industry Co. Ltd.

100 Clinical Results associated with Zhejiang Dier Medicine Industry Co. Ltd.

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0 Patents (Medical) associated with Zhejiang Dier Medicine Industry Co. Ltd.

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1

Literatures (Medical) associated with Zhejiang Dier Medicine Industry Co. Ltd.

Zhongguo Xinyao Zazhi

Efficacy and safety of cetirizine-pseudoephedrine sustained-release tablets in the treatment of seasonal and perennial allergic rhinitis

Author: Zheng, Wang-sheng ; Hu, Xian-yue ; Huang, Xiu-qing ; Wang, De-hui ; He, Zhen-yu ; Lou, Xiao-feng

Objective: To investigate the efficacy and safety of compound cetirizine hydrochloride and pseudoephedrine hydrochloride sustained-release tablets in the treatment of seasonal and perennial allergic rhinitis.Methods: In a randomized, double-blind, double-dummy and controlled trial, 210 patients were randomly assigned to the cetirizine-pseudoephedrine sustained-release tablet group and cetirizine hydrochloride capsules (control) group to conduct a systematic research.Results: After 7-day treatments, the scores of nasal blockage, runny nose, nasal itching and the overall severity of the disease were significantly reduced, and the efficacy of cetirizine-pseudoephedrine tablets was better than control capsules.The incidence of adverse events was not significantly different, and no serious adverse events occurred in both groups.Conclusion: Cetirizine-pseudoephedrine sustained-release tablet is a safe and effective drug in the treatment of seasonal or perennial allergic rhinitis.

100 Deals associated with Zhejiang Dier Medicine Industry Co. Ltd.

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100 Translational Medicine associated with Zhejiang Dier Medicine Industry Co. Ltd.

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Pipeline

Pipeline Snapshot as of 02 Feb 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

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