[Translation] A randomized, double-blind, placebo-controlled, dose-finding, multicenter phase IIa clinical trial of CZ130 capsules in the treatment of nonalcoholic fatty hepatitis (damp-heat accumulation type)

主要目的：初步探索不同剂量下CZ130胶囊对非酒精性脂肪性肝炎（湿热蕴结型）患者肝脏炎症的治疗效果；次要目的：（1）初步探索不同剂量下CZ130胶囊对非酒精性脂肪性肝炎（湿热蕴结型）患者的肝脏脂肪含量变化及肝脏纤维化改善情况；（2）初步探索不同剂量下CZ130胶囊治疗非酒精性脂肪性肝炎（湿热蕴结型）患者的安全性。

[Translation]

Primary purpose: To preliminarily explore the therapeutic effect of CZ130 capsules at different doses on liver inflammation in patients with non-alcoholic fatty liver disease (damp-heat accumulation type); Secondary purpose: (1) To preliminarily explore the effect of CZ130 capsules at different doses on the changes in liver fat content and improvement of liver fibrosis in patients with non-alcoholic fatty liver disease (damp-heat accumulation type); (2) To preliminarily explore the safety of CZ130 capsules at different doses in the treatment of patients with non-alcoholic fatty liver disease (damp-heat accumulation type).

Start Date27 May 2021

Sponsor / Collaborator

Nanjing Hongjing Medical Technology Co., Ltd.

CTR20181205 / CompletedPhase 1

岩黄连总碱胶囊在健康志愿者中多次给药耐受性和药代动力学探索的Ⅰ期临床研究

[Translation] Phase I clinical study on the tolerability and pharmacokinetics of Coptis chinensis total alkaloid capsules after repeated administration in healthy volunteers

1) 研究健康受试者多次口服岩黄连总碱胶囊的耐受性； 2) 探索健康受试者多次口服岩黄连总碱胶囊的人体药代动力学特征，为II期临床试验提供安全的剂量范围选择及给药方案依据提供参考。

[Translation]

1) To study the tolerance of healthy subjects to oral administration of Coptis chinensis Total Alkaloids Capsules for multiple times; 2) To explore the pharmacokinetic characteristics of Coptis chinensis Total Alkaloids Capsules for multiple times in healthy subjects, and to provide a reference for the selection of safe dose range and dosing regimen for Phase II clinical trials.

Start Date04 Jun 2018

Sponsor / Collaborator

Nanjing Hongjing Medical Technology Co., Ltd.

CTR20180412 / CompletedPhase 1

岩黄连总碱胶囊在健康志愿者中的单次给药耐受性和药代动力学探索的I期临床研究

[Translation] Phase I clinical study on single-dose tolerability and pharmacokinetics of Coptis chinensis total alkaloid capsule in healthy volunteers

主要目的：？研究健康受试者单次口服岩黄连总碱胶囊的耐受性？探索健康受试者单次口服岩黄连总碱胶囊的人体药代动力学特征

[Translation]

Main objectives: ? To study the tolerability of a single oral dose of Coptis chinensis total alkaloids capsules in healthy subjects ? To explore the pharmacokinetic characteristics of a single oral dose of Coptis chinensis total alkaloids capsules in healthy subjects

Start Date04 May 2017

Sponsor / Collaborator

Nanjing Hongjing Medical Technology Co., Ltd.

100 Clinical Results associated with Yanhuanglian Alkaloid Capsule

100 Translational Medicine associated with Yanhuanglian Alkaloid Capsule

100 Patents (Medical) associated with Yanhuanglian Alkaloid Capsule

Literatures (Medical) associated with Yanhuanglian Alkaloid Capsule

01 Jan 2010·Drug and Chemical ToxicologyQ4 · MEDICINE

Evaluation of genotoxicity ofYanhuangliandehydrocavidine (YHL-DC)in vitroandin vivo

Q4 · MEDICINE

Article

Author: Zhang Tianbao ; Zhu Jiangbo ; Ma Xili ; Wan Xuying ; Zhu Yuping

It is reported that dehydrocavidine (DC), the main component of a traditional Chinese medicine, Yanhuanglian (YHL), can protect hepatic tissue against HBV and HAV impairment. As part of a safety evaluation on YHL-DC for use in the treatment of HBV, the present study evaluated the potential genotoxicity of YHL-DC by using the standard battery of tests (i.e., bacterial reverse mutation, chromosomal aberrations, and mouse micronucleus assays) recommended by the State Food and Drug Administration of China. The results showed that YHL-DC was not genotoxic under the conditions of the reverse mutation, chromosomal aberrations, and mouse micronucleus assay conditions. The anticipated clinical dose should be smaller than the doses used in the genotoxicity assays. With confirmation from further toxicity studies, YHL-DC would hopefully prove to be a useful anti-HBV agent.

01 Jun 2006·Journal of Pharmaceutical and Biomedical AnalysisQ3 · MEDICINE

Bioavailabilty and pharmacokinetics of four active alkaloids of traditional Chinese medicine Yanhuanglian in rats following intravenous and oral administration

Q3 · MEDICINE

Article

Author: Xiao-Lin Wang ; Chuan Zhang ; Xiang-Wei Wang ; Run-Hui Liu ; Jian-Bao Zhu ; Chun-Lin Chen ; Wei-Dong Zhang ; Hui-Liang Li

Corydalis saxicola Bunting (Yanhuanglian) is an important component in various prescriptions in traditional Chinese medicine. Yanhuanglian has been demonstrated to possess many pharmacological activities, including antibacterial, antiviral and anticancer activities. The active fractions are dehydrocavidine, coptisine, dehydroapocavidine and tetradehydroscoulerine. The purpose of the present study was to examine in vivo pharmacokinetics and tissue distribution in rats by using high-performance liquid chromatography (HPLC) coupled with tandem mass spectrometry. Systemic clearance of the four active alkaloids in plasma was over 93% of hepatic blood flow, indicating they may be quickly eliminated via hepatic clearance. Less than 10% drugs was excreted via urine following intravenous and oral administration, suggesting that these four alkaloids may undergo significant metabolism in the body or the drug may be excreted via other routes other than urine. There was significantly lower excretion of these four alkaloids following oral than intravenous administration, suggesting a significant first pass effect after oral administration. There appeared to be wide distribution of those four alkaloids in rats as demonstrated by the higher apparent volume of distribution. Our results have also demonstrated that the four alkaloids can be absorbed following oral administration although there were less than 15% of drugs absorbed into systemic circulation. In summary, the favorable oral bioavailability properties of those four active alkaloids in rats make Yanhuanglian extract worth further investigation for improving oral bioavailability.

100 Deals associated with Yanhuanglian Alkaloid Capsule

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nonalcoholic Steatohepatitis	Phase 2	CN	Nanjing Hongjing Medical Technology Co., Ltd.	27 May 2021
Acute hepatitis	Discovery	CN	Nanjing Hongjing Medical Technology Co., Ltd.	04 May 2017
Feeding and Eating Disorders	Discovery	CN	Nanjing Hongjing Medical Technology Co., Ltd.	04 May 2017
Hepatitis, Chronic	Discovery	CN	Nanjing Hongjing Medical Technology Co., Ltd.	04 May 2017

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