更新于：2024-11-04
Calcium Dobesilate
羟苯磺酸钙
更新于：2024-11-04
概要
基本信息
原研机构- |
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C12H12CaO10S2 |
InChIKeyAEWLOKQYGXDGFV-UHFFFAOYSA-N |
CAS号20123-80-2 |
关联
57
项与 羟苯磺酸钙 相关的临床试验Fasted-state in vivo bioequivalence study of Calcium Dobesilate 500 mg Capsule manufactured by Abyan Pharmed compared with innovator product
羟苯磺酸钙胶囊在健康成年受试者空腹和餐后条件下、单中心、随机、开放、单次给药、两周期、两序列、自身交叉对照中的人体生物等效性试验
中国健康受试者空腹及餐后状态下单次口服羟苯磺酸钙胶囊的单中心、开放、随机、两制剂、两序列、两周期、双交叉人体生物等效性试验
100 项与 羟苯磺酸钙 相关的临床结果
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100 项与 羟苯磺酸钙 相关的转化医学
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100 项与 羟苯磺酸钙 相关的专利（医药）
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334
项与 羟苯磺酸钙 相关的文献（医药）2024-11-01Biotechnology & genetic engineering reviews
Clinical study on prescription used for invigorating spleen, reinforcing kidney and warming yang combined with calcium dobesilate in treatment of senile diabetic nephropathy
Article
作者: Zhu, Lin ; Zhao, Jianqun ; Li, Qian
OBJECTIVE:
To analyze the clinical effect of prescription used for invigorating spleen, reinforcing kidney and warming yang combined with calcium dobesilate to treat senile diabetic nephropathy (DN).
METHODS:
The clinical data of 110 elderly patients with DN in our hospital from November 2020 to November 2021 were selected for retrospective analysis, and they were divided into the observation group (OG, n = 55) and the control group (CG, n = 55) according to the principle of random grouping. The CG received conventional therapy and calcium dobesilate, and the OG received conventional therapy, calcium dobesilate and prescription used for invigorating spleen, reinforcing kidney and warming yang to evaluate the clinical value of different treatment programs by comparing their clinical indicators after treatment.
RESULTS:
The total effective rate of clinical treatment in the OG was clearly higher than the CG (P < 0.05). The blood glucose indexes, and the levels of ALB and RBP in the OG were visibly lower than the CG after treatment (P < 0.001). After treatment, the average levels of BUN and Cr in the OG were visibly lower than the CG (P < 0.001), while the average eGFR level was significantly higher than the CG (P < 0.001).
CONCLUSION:
The prescription used for invigorating spleen, reinforcing kidney and warming yang combined with calcium dobesilate is a reliable method to improve the hemorheology indexes and renal function of DN patients, which benefits patients, and further studies are helpful to establish a better solution for such patients.
2024-05-01BMJ Open
Study protocol for assessment of the efficacy of calcium dobesilate versus placebo on SARS-CoV-2 viral load in outpatients with COVID-19 (CADOVID study): a randomised, placebo-controlled, double-blind, monocentric phase II trial
Article
作者: Gosmain, Yvan ; Salamun, Julien ; Spechbach, Herve ; Ustero, Pilar ; Calmy, Alexandra ; Da Silva, Tamara ; Guessous, Idris
Introduction:
SARS-CoV-2 mainly infects respiratory endothelial cells, which is facilitated through its spike protein binding to heparan sulphate. Calcium dobesilate (CaD) is a well-established, widely available vasoactive and angioprotective drug interacting with heparan sulphate, with the potential to interfere with the uptake of SARS-CoV-2 by epithelial cells. The CADOVID trial aims to evaluate the efficacy and safety of CaD in reducing the SARS-CoV-2 viral load in non-hospitalised adult patients diagnosed with COVID-19, confirmed by a positive SARS-CoV-2 PCR, including its efficacy to reduce the impact of persistent COVID-19 symptoms.
Methods and analysis:
This is a randomised, placebo-controlled, double-blind, monocentric phase II trial. Enrolment began in July 2022. A total of 74 adult patients will be randomly allocated to the CaD arm or the placebo group with a 1:1 ratio, respectively. Participants in the intervention arm will receive two capsules of CaD 500 mg two times per day and the placebo arm will receive two matching capsules of mannitol 312.5 mg two times per day, with a treatment period of 7 days for both arms, followed by a 77-day observational period without treatment administration. Participants will be asked to complete secured online questionnaires using their personal smartphone or other electronic device. These include a COVID-19 questionnaire (assessing symptoms, temperature measurement, reporting of concomitant medication and adverse events), a COVID-19 persistent symptoms’ questionnaire and the Short Form 12-Item (SF-12) survey. SARS-CoV-2 PCR testing will be performed on nasopharyngeal swabs collected on days 1, 4, 8 and 21. The primary endpoint is the reduction from baseline of SARS-CoV-2 viral load determined by RT-PCR at day 4.
Ethics and dissemination:
This trial has received approval by the Geneva Regional Research Ethics Committee (2022-00613) and Swissmedic (701339). Dissemination of results will be through presentations at scientific conferences and publication in scientific journals.
Trial registration number:
NCT05305508; Clinicaltrials.gov; Swiss National Clinical Portal Registry (SNCTP 000004938).
2024-04-01Clinical pharmacology in drug development
Pharmacokinetics, Bioequivalence, and Safety Evaluation of Two Oral Formulations of Calcium Dobesilate Capsules in Healthy Chinese Volunteers Under Fasting and Fed Conditions
Article
作者: Liu, Ying ; Chen, Ran ; Wang, Yanrong ; Dai, Xinya ; Li, Hongmin ; Wang, Fengqin ; Gao, Jie ; Tang, Liyuan
Abstract:
To determine the pharmacokinetics (PK), safety, and bioequivalence profiles of 0.5‐g calcium dobesilate capsules in both fasting and fed states for the test drug and reference drug. A randomized‐sequence, single‐dose, open‐label, 2‐period crossover study was conducted in fasted and fed healthy Chinese volunteers (Chinese Clinical Trials Registry identifier: CTR202000268‐01). The fasting and fed studies, both involving 24 subjects, were conducted. A single dosage of either the reference or the test preparation was given to each eligible subject in a 1:1 ratio, followed by a 7‐day rest interval before the administration of the alternative formulation. After taking the capsules, plasma samples were taken for 48 hours, and using liquid chromatography‐tandem mass spectrometry, the calcium dobesilate level was determined. The PK parameters evaluated in the study included the maximum serum concentration (Cmax), area under the plasma concentration‐time curve (AUC) from time 0 to the last quantifiable concentration, AUC from time 0 to infinity, half‐life, time to Cmax, and terminal elimination rate constant. In addition, the safety evaluation encompassed monitoring fluctuations in vitals (temperature, pulse, and blood pressure) and laboratory tests (urinalysis, hepatic function, blood biochemistry, and hematology), as well as recording the emergence of adverse events (AEs). The geometric mean ratio (GMR) of the test/reference medications was used to assess bioequivalence by determining if the 90% confidence intervals of the GMR fell within the predefined range of 80%‐125%. AEs were assessed as safety end points. The study included 48 healthy Chinese volunteers (with n = 24 each for the fasting and the fed conditions), and no subjects dropped out for any reason. The differences in the PK metrics for the test and reference drugs for both conditions were insignificant (P > .05). For bioequivalence, irrespective of whether the food was consumed or not, the range of the 90% confidence intervals of the GMR for Cmax, AUC from time 0 to the last quantifiable concentration, and AUC from time 0 to infinity was between 80% and 125%. In the experiment, no serious AEs were recorded. Our findings revealed that the calcium dobesilate capsules used as the reference and the test drugs were both bioequivalent. Irrespective of whether the healthy Chinese volunteers consumed food or not, the PK and safety profiles were comparable.
100 项与 羟苯磺酸钙 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 动脉硬化闭塞症 | 中国 | 1992-07-04 | |
| 慢性静脉功能不全 | 中国 | 1992-07-04 | |
| 高血压 | 中国 | 1992-07-04 | |
| 微血管疾病 | 中国 | 1992-07-04 | |
| 静脉炎 | 中国 | 1992-07-04 | |
| 痉挛 | 中国 | 1992-07-04 | |
| 溃疡 | 中国 | 1992-07-04 | |
| 静脉曲张 | 中国 | 1992-07-04 | |
| 糖尿病性视网膜病变 | 韩国 | 1988-01-19 | |
| 水肿 | 韩国 | 1988-01-19 | |
| 痔疮 | 韩国 | 1988-01-19 | |
| 血栓后综合征 | 韩国 | 1988-01-19 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 糖尿病肾病 | 临床前 | - | 2018-10-23 |
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临床结果
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适应症
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N/A | - | 顧鑰繭顧鑰顧願網壓鹹(選餘積糧遞憲築糧鹽觸) = 糧廠淵鬱窪壓鏇選齋醖 鏇艱鑰蓋範顧築糧廠襯 (鬱網築鏇夢憲網範獵糧 ) 更多 | - | 2009-04-01 | |||
N/A | 194 | 選蓋簾鏇願膚鏇鑰襯蓋(淵選遞繭襯顧觸製鬱網): P-Value = p0.044 | - | 2004-05-01 | |||
Placebo | |||||||
N/A | 糖尿病性视网膜病变 type 2 diabetes | 194 | Doxium® (DX) 2g | 壓醖鹹製網鏇膚鹹膚築(糧窪鬱憲顧齋窪膚築淵): P-Value = 0.0016 | 积极 | 2004-05-01 | |
Placebo |
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