Delving into the Latest Updates on Calcium Dobesilate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Calcium Dobesilate Capsules, Calcium Dobesilate Granules, Calcium dobesilate (INN)

+ [9]

Target

VEGFR2

Mechanism

VEGFR2 antagonists(Vascular endothelial growth factor receptor 2 antagonists)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesDigestive System Disorders+ [4]

Active Indication

Arteriosclerosis ObliteransChronic venous insufficiencyHypertension+ [10]

Inactive Indication-

Originator Organization-

Active Organization

ILSUNG IS Co., Ltd.

Hannover Medical SchoolVifor Pharma Österreich GmbH

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

KR (19 Jan 1988),

Diabetic RetinopathyEdemaHemorrhoids+ [1]

Regulation-

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Structure

Molecular FormulaC12H12CaO10S2

InChIKeyAEWLOKQYGXDGFV-UHFFFAOYSA-N

CAS Registry20123-80-2

主要研究目的：以广东华南药业集团有限公司生产的羟苯磺酸钙胶囊（规格：0.5g）为受试制剂，以Klocke Pharma Service生产的羟苯磺酸钙胶囊（商品名：Doxium®，规格：0.5g）为参比制剂，研究受试制剂与参比制剂的吸收速度和吸收程度，评价两制剂在空腹/餐后条件下单次给药时的生物等效性。次要研究目的：观察在空腹/餐后条件下单次口服两制剂在健康受试者中的安全性。

[Translation]

The main purpose of the study is to use calcium dobesilate capsules (specification: 0.5g) produced by Guangdong South China Pharmaceutical Group Co., Ltd. as the test preparation and calcium dobesilate capsules (trade name: Doxium®, specification: 0.5g) produced by Klocke Pharma Service as the reference preparation to study the absorption rate and extent of the test preparation and the reference preparation, and to evaluate the bioequivalence of the two preparations when administered in a single dose under fasting/postprandial conditions. Secondary purpose of the study: To observe the safety of the two preparations in healthy subjects when administered orally in a single dose under fasting/postprandial conditions.

Start Date05 Aug 2023

Sponsor / Collaborator

Guangdong Huanan Pharmaceutical Group Co. Ltd.

CTR20231381 / CompletedNot Applicable

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

[Translation] A single-center, open-label, randomized, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of calcium dobesilate capsules in Chinese healthy volunteers in the fasting and fed state

研究健康受试者空腹及餐后单次口服受试制剂羟苯磺酸钙胶囊（海南斯达制药有限公司，规格：0.5g）与参比制剂羟苯磺酸钙胶囊（商品名：Doxium ®，规格：0.5g）在吸收程度和速度方面是否存在差异，评价受试制剂和参比制剂在空腹及餐后条件下给药时的生物等效性，观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

To study whether there are differences in the extent and rate of absorption between the test preparation calcium dobesilate capsules (Hainan Star Pharmaceutical Co., Ltd., specification: 0.5g) and the reference preparation calcium dobesilate capsules (trade name: Doxium ®, specification: 0.5g) after a single oral administration on an empty stomach or after a meal in healthy subjects, to evaluate the bioequivalence of the test preparation and the reference preparation when administered on an empty stomach or after a meal, and to observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date24 Jun 2023

Sponsor / Collaborator

Hainan Star Pharmaceutical Co., Ltd.

100 Clinical Results associated with Calcium Dobesilate

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100 Translational Medicine associated with Calcium Dobesilate

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100 Patents (Medical) associated with Calcium Dobesilate

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335

Literatures (Medical) associated with Calcium Dobesilate

01 Nov 2024·Biotechnology and 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

Author: Zhu, Lin ; Zhao, Jianqun ; Li, Qian

OBJECTIVETo 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).METHODSThe 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.RESULTSThe 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).CONCLUSIONThe 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.

01 May 2024·BMJ 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

Author: Spechbach, Herve ; Salamun, Julien ; Guessous, Idris ; Da Silva, Tamara ; Calmy, Alexandra ; Ustero, Pilar ; Gosmain, Yvan

IntroductionSARS-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 analysisThis 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 disseminationThis 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 numberNCT05305508; Clinicaltrials.gov; Swiss National Clinical Portal Registry (SNCTP 000004938).

01 Apr 2024·Clinical 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

Author: Liu, Ying ; Chen, Ran ; Gao, Jie ; Li, Hongmin ; Dai, Xinya ; Tang, Liyuan ; Wang, Yanrong ; Wang, Fengqin

AbstractTo 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 Deals associated with Calcium Dobesilate

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External Link

KEGG	Wiki	ATC	Drug Bank
D07427	Calcium Dobesilate	C05BX01	DBSALT002519

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Arteriosclerosis Obliterans	CN	Vifor Pharma Österreich GmbH	04 Jul 1992
Chronic venous insufficiency	CN	Vifor Pharma Österreich GmbH	04 Jul 1992
Hypertension	CN	ILSUNG IS Co., Ltd.	04 Jul 1992
Microvascular Disease	CN	Vifor Pharma Österreich GmbH	04 Jul 1992
Phlebitis	CN	Vifor Pharma Österreich GmbH	04 Jul 1992
Spasm	CN	Vifor Pharma Österreich GmbH	04 Jul 1992
Ulcer	CN	Vifor Pharma Österreich GmbH	04 Jul 1992
Varicose Veins	CN	Vifor Pharma Österreich GmbH	04 Jul 1992
Diabetic Retinopathy	KR	ILSUNG IS Co., Ltd.	19 Jan 1988
Edema	KR	ILSUNG IS Co., Ltd.	19 Jan 1988
Hemorrhoids	KR	ILSUNG IS Co., Ltd.	19 Jan 1988
Postthrombotic Syndrome	KR	ILSUNG IS Co., Ltd.	19 Jan 1988

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic Nephropathies	Preclinical	-	Hannover Medical School	23 Oct 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ARVO2009	Not Applicable	Diabetes Mellitus	-	Calcium Dobesilate	ttoficdhlu(tadmchwcnr) = tgxrwepfsk jytydjudfu (vwagbusbrc ) View more	-	01 Apr 2009
ARVO2004	Not Applicable	Diabetic Retinopathy	194	Doxium 2g/day	ijqcyhhiiv(bglbwyrtrh): P-Value = p0.044	-	01 May 2004
ARVO2004	Not Applicable	Diabetic Retinopathy	194	Placebo	ijqcyhhiiv(bglbwyrtrh): P-Value = p0.044	-	01 May 2004