主要研究目的：考察空腹及餐后状态下单次口服受试制剂复方甘草酸苷片（规格：每片含甘草酸苷25 mg、甘氨酸25 mg、DL-蛋氨酸25 mg，浙江华海药业股份有限公司提供）与参比制剂复方甘草酸苷片（美能/Stronger Neo-Minophagen C，规格：每片含甘草酸苷25 mg、甘氨酸25 mg、DL-蛋氨酸25 mg；Minophagen Pharmaceutical Co., Ltd.持证）在成年参与者体内的药代动力学特征，评价空腹及餐后状态口服两种制剂的生物等效性。次要研究目的：考察受试制剂复方甘草酸苷片（规格：每片含甘草酸苷25 mg、甘氨酸25 mg、DL-蛋氨酸25 mg）和参比制剂复方甘草酸苷片（美能/Stronger Neo-Minophagen C）（规格：每片含甘草酸苷25 mg、甘氨酸25 mg、DL-蛋氨酸25 mg）在成年参与者中的安全性。

[Translation]

Main research objectives: To investigate the pharmacokinetic characteristics of the test preparation compound glycyrrhizin tablets (specifications: each tablet contains 25 mg glycyrrhizin, 25 mg glycine, 25 mg DL-methionine, provided by Zhejiang Huahai Pharmaceutical Co., Ltd.) and the reference preparation compound glycyrrhizin tablets (Stronger Neo-Minophagen C, specifications: each tablet contains 25 mg glycyrrhizin, 25 mg glycine, 25 mg DL-methionine; Minophagen Pharmaceutical Co., Ltd.) in adult participants after a single oral administration in fasting and fed state, and to evaluate the bioequivalence of the two preparations in fasting and fed state. Secondary study objective: To investigate the safety of the test preparation Compound Glycyrrhizin Tablets (Specifications: each tablet contains 25 mg glycyrrhizin, 25 mg glycine, and 25 mg DL-methionine) and the reference preparation Compound Glycyrrhizin Tablets (Stronger Neo-Minophagen C) (Specifications: each tablet contains 25 mg glycyrrhizin, 25 mg glycine, and 25 mg DL-methionine) in adult participants.

Start Date18 Sep 2024

Sponsor / Collaborator

Zhejiang Huahai Pharmaceutical Co., Ltd.

CTR20233608 / CompletedNot Applicable

复方甘草酸苷片人体生物等效性研究

[Translation] Study on the bioequivalence of compound glycyrrhizic acid tablets in healthy volunteers

采用单中心、随机、开放、四周期完全重复交叉设计、单剂量设计比较空腹和餐后给药条件下，北京远方通达医药技术有限公司提供的复方甘草酸苷片（规格：每片含甘草酸单铵盐35 mg（甘草酸苷25 mg）、甘氨酸25 mg、DL-蛋氨酸25 mg）与Minophagen Pharmaceutical Co., Ltd.持证的复方甘草酸苷片（规格：每片含甘草酸单铵盐35 mg（甘草酸苷25 mg）、甘氨酸25 mg、DL-蛋氨酸25 mg；商品名：美能®/Stronger Neo-Minophagen C®）在健康人群中吸收程度和速度的差异，并评价北京远方通达医药技术有限公司提供的复方甘草酸苷片与与Minophagen Pharmaceutical Co., Ltd.持证的复方甘草酸苷片的安全性和耐受性

[Translation]

A single-center, randomized, open-label, four-period completely repeated crossover design and single-dose design were used to compare the differences in absorption extent and rate between the compound glycyrrhizic acid tablets (specifications: each tablet contains 35 mg monoammonium glycyrrhizic acid (25 mg glycyrrhizic acid), 25 mg glycine, and 25 mg DL-methionine) provided by Beijing Yuanfangtongda Pharmaceutical Technology Co., Ltd. and the compound glycyrrhizic acid tablets (specifications: each tablet contains 35 mg monoammonium glycyrrhizic acid (25 mg glycyrrhizic acid), 25 mg glycine, and 25 mg DL-methionine; trade name: Minophagen®/Stronger Neo-Minophagen C®) certified by Minophagen Pharmaceutical Co., Ltd. under fasting and postprandial administration conditions in healthy people, and to evaluate the safety and tolerability of the compound glycyrrhizic acid tablets provided by Beijing Yuanfangtongda Pharmaceutical Technology Co., Ltd. and the compound glycyrrhizic acid tablets certified by Minophagen Pharmaceutical Co., Ltd.

Start Date07 Dec 2023

Sponsor / Collaborator

Beijing Yuanfang Tongda Pharmaceutical Technology Co., Ltd.

CTR20231678 / CompletedNot Applicable

复方甘草酸苷片人体生物等效性研究

[Translation] Study on the bioequivalence of compound glycyrrhizic acid tablets in healthy volunteers

分别采用单中心、随机、开放、交叉、单剂量、空腹和餐后给药设计评价成都倍特药业股份有限公司提供的复方甘草酸苷片为受试制剂和Minophagen Pharmaceutical Co.,Ltd.持证的复方甘草酸苷片（商品名：美能®/Stronger Neo-Minophagen C®）为参比制剂在健康人群空腹、餐后口服的吸收程度和吸收速度的差异，评价两制剂的生物等效性，并评价成都倍特药业股份有限公司提供的复方甘草酸苷片与Minophagen Pharmaceutical Co., Ltd.持证的复方甘草酸苷片的安全性。

[Translation]

A single-center, randomized, open, crossover, single-dose, fasting and postprandial administration design was used to evaluate the differences in the extent and rate of oral absorption of the compound glycyrrhizic acid tablets provided by Chengdu Beite Pharmaceutical Co., Ltd. as the test preparation and the compound glycyrrhizic acid tablets (trade name: Stronger Neo-Minophagen C®) certified by Minophagen Pharmaceutical Co., Ltd. as the reference preparation in healthy people on an empty stomach and after a meal, to evaluate the bioequivalence of the two preparations, and to evaluate the safety of the compound glycyrrhizic acid tablets provided by Chengdu Beite Pharmaceutical Co., Ltd. and the compound glycyrrhizic acid tablets certified by Minophagen Pharmaceutical Co., Ltd.

Start Date02 Jun 2023

Sponsor / Collaborator

Brilliant Pharmaceutical Co. Ltd.

100 Clinical Results associated with Compound Glycyrrhizin

100 Translational Medicine associated with Compound Glycyrrhizin

100 Patents (Medical) associated with Compound Glycyrrhizin

Literatures (Medical) associated with Compound Glycyrrhizin

01 Nov 2023·Pigment Cell & Melanoma Research

Unveiling the mystery of Riehl's melanosis: An update from pathogenesis, diagnosis to treatment

Review

Author: Ding, Yuecen ; Xiang, Leihong Flora ; Xu, Zhongyi ; Zhang, Chengfeng

AbstractRiehl's melanosis is a hyperpigmentation disorder that has a significant psychological and social impact on individuals. In the past 10 years, new categories have been developed, raising questions about how to classify Riehl's melanosis. The mechanism of this disease remains unclear, although the type IV hypersensitivity response caused by allergic sensitization, as well as genetic, ultraviolet radiation, and autoimmune factors, is to blame. Clinical manifestation, dermoscopy, reflectance confocal microscopy, patch/photopatch testing, histopathology, and a novel multimodality skin imaging system have been used for the diagnosis. A variety of therapies including topical skin‐lightening agents, oral tranexamic acid, glycyrrhizin compound, chemical peels, and lasers and light therapies (intense pulsed light, 1064‐nm Q‐Switched Nd: YAG laser, 755‐nm PicoWay laser, nonablative 1927‐nm fractional thulium fiber laser, new pulsed‐type microneedling radiofrequency), with improved effectiveness. The latest findings on possible biomarkers and their relationship to other autoimmune diseases were also summarized.

01 Jun 2020·Journal of Cosmetic DermatologyQ4 · MEDICINE

Combination therapy with salicylic acid chemical peels, glycyrrhizin compound, and vitamin C for Riehl's melanosis

Q4 · MEDICINE

Article

Author: Hao, Dan ; Jiang, Xian ; Wen, Xiang ; Wang, Lian ; Li, Yong ; Du, Dan

AbstractBackgroundRiehl's melanosis is a chronic, refractory disorder, which can adversely affect patient's quality of life. Intense pulse light, neodymium‐doped yttrium aluminum garnet laser, hydroquinone, tranexamic acid have been reported to treat this disease, but there have been few reports on the effectiveness of other treatments.AimTo assess the efficacy and safety of triple combination therapy with salicylic acid chemical peels, oral glycyrrhizin compound, and vitamin C for Riehl's melanosis.Patients/MethodsThree patients diagnosed with Riehl's melanosis were enrolled. All patients were treated with glycyrrhizin compound (150 mg/d), vitamin C (100 mg/d), and salicylic acid 30% peels once every 2 weeks. Clinical photographs and VISIA were used to assess the efficacy.ResultsAll patients received obvious improvement and reported no obvious side effects.ConclusionTriple combination therapy with salicylic acid peels, oral glycyrrhizin compound, and vitamin C is a safe and effective modality for Riehl's melanosis.

01 May 2020·QJM: An International Journal of MedicineQ4 · MEDICINE

Dimethylacetamide-induced toxic hepatitis in spandex workers: clinical presentation and treatment outcomes

Q4 · MEDICINE

Article

Author: Wang, J ; Chen, G

AbstractBackgroundDimethylacetamide (DMAc) exposure has been associated with toxic hepatitis, and no clinical treatment has been reported.AimTo investigate the clinical manifestations of DMAc-induced symptoms and how to rescue the functional loss due to occupational exposure.DesignClinical observations of 60 spandex factory workers with the exposure to DMAc from January, 2017–19.MethodsChinese drugs (reduced glutathione, polyene phosphatidylcholine, glycyrrhizin compound, Hugan tablets and ornithine aspartate) were used to evaluate the therapeutic improvements in DMAc-exposed patients.ResultsOur data found that 58.3% patients had no distinct clinical symptoms, but 41.7% patients felt fatigue, and 21.7% patients suffered abdominal discomfort and appetite loss, and 8.3% patients had yellow skin and sclera. The ultrasonic and CT imaging revealed that some patients have fatty livers, intrahepatic calcifications, hepatomegaly, gallbladder wall edema and abdominal effusions. Biochemical analysis showed that the alanine aminotransferase (ALT) (P < 0.001), aspartate aminotransferase (AST) (P < 0.001), lactate dehydrogenase (LDH) (P < 0.001) and bilirubin (P < 0.01) statistically decreased after the drug treatment, but alkaline phosphatase (P >0.05) and glutamyl transpeptidase (P> 0.05) did not decrease. Twenty-nine out of the thirty-one patients’ abnormal blood ammonia recovered. The risk factor of ALT on hospitalization time was significantly related (P < 0.01).ConclusionsThe drugs above are sufficient to rescue functional loss in DMAc-induced toxic hepatitis, in part via the regulations of ALT, AST, LDH, bilirubin and ammonia. Workers with the exposure to DMAc should receive specific drugs to maintain the health and prevent functional loss in the long term.

100 Deals associated with Compound Glycyrrhizin

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Alopecia Areata	CN	Beijing Kawin Technology Share-Holding Co., Ltd.	07 Jan 2008
Chronic liver disease	CN	Beijing Kawin Technology Share-Holding Co., Ltd.	07 Jan 2008
Eczema	CN	Beijing Kawin Technology Share-Holding Co., Ltd.	07 Jan 2008

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