Delving into the Latest Updates on Herba Desmodii Styracifolii Flavonoids Capsule with Synapse

Overview

Basic Info

Drug Type

Herbal medicine

Synonyms-

Target-

Action-

Mechanism-

Therapeutic Areas

Urogenital Diseases

Active Indication

Calculus, Ureteral

Inactive Indication-

Originator Organization

Wuhan Optical Valley Humanwell Biological Pharmaceutical Co.

Active Organization

Wuhan Optical Valley Humanwell Biological Pharmaceutical Co.

Inactive Organization

Chinese People's Liberation Army General HospitalBeijing Haitai United Pharmaceutical Technology Development Co., Ltd.

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (14 Sep 2022),

Calculus, Ureteral

Regulation-

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主要研究目的鉴定广金钱草总黄酮胶囊在体内的主要成分及代谢物，明确血浆中的主要吸收成分和主要代谢产物。次要研究目的测试广金钱草总黄酮胶囊在人体内的药代动力学参数；给出血药浓度半定量测试方法与结果；观察广金钱草总黄酮胶囊多次口服给药在健康受试者中的安全性。

[Translation]

The main purpose of the study is to identify the main components and metabolites of Herba Lysimachiae Total Flavonoids Capsules in the body, and to clarify the main absorbed components and main metabolites in plasma. The secondary purpose of the study is to test the pharmacokinetic parameters of Herba Lysimachiae Total Flavonoids Capsules in humans; to provide a semi-quantitative test method and results for blood drug concentration; to observe the safety of Herba Lysimachiae Total Flavonoids Capsules after multiple oral administration in healthy subjects.

Start Date18 Nov 2019

Sponsor / Collaborator

Chinese People's Liberation Army General Hospital

[+1]

CTR20171264

/ CompletedPhase 3

广金钱草总黄酮胶囊治疗输尿管结石的随机、双盲、安慰剂平行对照、多中心Ⅲ期临床试验

[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of total flavonoids capsules of Lysimachia sibiricum in the treatment of ureteral calculi

进一步验证广金钱草总黄酮胶囊治疗输尿管结石的有效性和安全性，评价利益与风险关系，为药物注册申请提供充分的依据。

[Translation]

Further verify the effectiveness and safety of total flavonoids capsules from Desmodium sibiricum in the treatment of ureteral stones, evaluate the benefit-risk relationship, and provide sufficient basis for drug registration applications.

Start Date27 Dec 2017

Sponsor / Collaborator

Chinese People's Liberation Army General Hospital

[+1]

CTR20140223

/ CompletedPhase 3

广金钱草总黄酮胶囊治疗尿路结石有效性、安全性的随机、双盲、模拟剂平行对照、多中心Ⅲ期临床试验

[Translation] A randomized, double-blind, sham-controlled, multicenter phase III clinical trial on the efficacy and safety of total flavonoids capsules of Lysimachia sibiricum in the treatment of urinary tract stones

进一步验证广金钱草总黄酮胶囊治疗尿路结石的有效性和安全性，评价利益与风险关系，最终为药物注册申请的审查提供充分的依据。

[Translation]

Further verify the effectiveness and safety of Desmodium sibiricum Total Flavonoids Capsules in the treatment of urinary tract stones, evaluate the benefit-risk relationship, and ultimately provide sufficient basis for the review of drug registration applications.

Start Date16 Jul 2014

Sponsor / Collaborator

Chinese People's Liberation Army General Hospital

[+1]

100 Clinical Results associated with Herba Desmodii Styracifolii Flavonoids Capsule

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100 Translational Medicine associated with Herba Desmodii Styracifolii Flavonoids Capsule

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100 Patents (Medical) associated with Herba Desmodii Styracifolii Flavonoids Capsule

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100 Deals associated with Herba Desmodii Styracifolii Flavonoids Capsule

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