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

Overview

Tags

Nervous System 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

Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	2

Top 5 Target	Count

NET(Norepinephrine transporter)	1
NET x μ opioid receptor	1

主要目的：以持证商为Teijin Pharma Limited.的非布司他片（商品名：Feburic®（菲布力®），规格：40mg）为参比制剂，以多多药业有限公司研发的非布司他片（40mg）为受试制剂，评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。次要目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the two preparations in Chinese healthy subjects in the fasting and fed state, using febuxostat tablets (trade name: Feburic®, specification: 40 mg) from Teijin Pharma Limited as the reference preparation and febuxostat tablets (40 mg) developed by Duoduo Pharmaceutical Co., Ltd. as the test preparation. Secondary objective: To observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.

Start Date04 Jul 2024

Sponsor / Collaborator

DUO Pharmaceutical Co., Ltd.

CTR20211761 / CompletedNot Applicable

评估受试制剂氨酚曲马多片与参比制剂氨酚曲马多片在健康成年受试者中空腹/餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test preparation, tramadol acetaminophen tablets, and the reference preparation, tramadol acetaminophen tablets, in healthy adult subjects under fasting/fed conditions

主要研究目的：考察单次单剂量口服（空腹/餐后）受试制剂氨酚曲马多片（规格：盐酸曲马多37.5mg/对乙酰氨基酚325mg（1片），多多药业有限公司生产）与参比制剂氨酚曲马多片（ULTRACET®，规格：盐酸曲马多37.5mg/对乙酰氨基酚325mg（1片），JANSSEN PHARMACEUTICALSINC生产），在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为该药的申报及临床用药提供参考依据。次要研究目的：评价空腹、餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。

[Translation]

The main purpose of the study is to investigate the relative bioavailability of a single oral dose (fasting/postprandial) of the test preparation Tramadol Amide Tablets (Specifications: Tramadol Hydrochloride 37.5mg/Acetaminophen 325mg (1 tablet), produced by Duoduo Pharmaceutical Co., Ltd.) and the reference preparation Tramadol Amide Tablets (ULTRACET®, Specifications: Tramadol Hydrochloride 37.5mg/Acetaminophen 325mg (1 tablet), produced by JANSSEN PHARMACEUTICALSINC) in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug. The secondary purpose of the study is to evaluate the safety of the test preparation and the reference preparation in Chinese healthy adult subjects after a single oral dose (fasting/postprandial).

Start Date07 Aug 2021

Sponsor / Collaborator

DUO Pharmaceutical Co., Ltd.

CTR20191723 / Completed

盐酸曲马多片单中心、随机、开放、双周期、自身交叉空腹及餐后人体生物等效研究

[Translation] A single-center, randomized, open-label, two-period, self-crossover bioequivalence study of tramadol hydrochloride tablets in fasting and fed subjects

采用单中心、随机、开放、双周期、自身交叉、单剂量给药评价多多药业有限公司生产的盐酸曲马多片（50 mg/片）与Janssen Ortho LLC生产的盐酸曲马多片（商品名：ULTRAM®，规格：50 mg/片）在健康人群空腹、餐后口服的生物等效性，为多多药业有限公司与Janssen Ortho LLC盐酸曲马多片临床疗效的一致性提供证据。初步评价空腹、餐后多多药业有限公司盐酸曲马多片的安全性。

[Translation]

A single-center, randomized, open, two-period, self-crossover, single-dose administration study was used to evaluate the bioequivalence of tramadol hydrochloride tablets (50 mg/tablet) produced by Duoduo Pharmaceutical Co., Ltd. and tramadol hydrochloride tablets (trade name: ULTRAM®, specification: 50 mg/tablet) produced by Janssen Ortho LLC in healthy people when taken orally on an empty stomach or after a meal, providing evidence for the consistency of clinical efficacy of tramadol hydrochloride tablets of Duoduo Pharmaceutical Co., Ltd. and Janssen Ortho LLC. The safety of tramadol hydrochloride tablets of Duoduo Pharmaceutical Co., Ltd. when taken orally on an empty stomach or after a meal was preliminarily evaluated.

Start Date04 Sep 2019

Sponsor / Collaborator

DUO Pharmaceutical Co., Ltd.

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

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

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100 Deals associated with DUO Pharmaceutical Co., Ltd.

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

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Pipeline

Pipeline Snapshot as of 07 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

2

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