[Translation] A human bioequivalence clinical trial of Asartan Potassium Tablets after single administration in healthy Chinese people under the fed state

主要目的：以持证商为Takeda Pharma A/S的美阿沙坦钾片（商品名：易达比®（EDARBI®），规格：按美阿沙坦（C30H24N4O8）计80mg）为参比制剂，以杭州端本医药科技有限公司研发的美阿沙坦钾片（规格：按美阿沙坦（C30H24N4O8）计80mg）为受试制剂，评价两种制剂在中国健康受试者中餐后状态下的生物等效性。次要目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the two preparations in the postprandial state in healthy Chinese subjects, using the reference preparation of edartan potassium tablets (trade name: EDARBI®, specification: 80 mg based on edartan (C30H24N4O8)) developed by Hangzhou Duanben Pharmaceutical Technology Co., Ltd. as the test preparation. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date25 Dec 2024

Sponsor / Collaborator

Hangzhou Duanben Pharmaceutical Technology Co., Ltd.

CTR20243698

/ CompletedNot Applicable

美阿沙坦钾片在健康受试者空腹和餐后状态下的随机、开放、单剂量、两制剂、两序列、两周期、交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, crossover bioequivalence study of Asartan Potassium Tablets in healthy subjects under fasting and fed conditions

主要目的：比较空腹和餐后单次给药条件下，珠海润都制药股份有限公司生产的美阿沙坦钾片（规格：80mg）与Takeda Pharma A/S持证的美阿沙坦钾片（商品名：易达比®/EDARBI®，规格：80mg）在健康受试者中吸收程度和速度的差异。通过主要药代动力学参数，评价两者是否生物等效。次要目的：通过观察健康受试者单次口服受试制剂和参比制剂后的安全性指标，评价美阿沙坦钾片的安全性。

[Translation]

Primary objective: To compare the differences in the extent and rate of absorption of Asartan Potassium Tablets (specification: 80 mg) produced by Zhuhai Rundu Pharmaceutical Co., Ltd. and Asartan Potassium Tablets (trade name: EDARBI®/EDARBI®, specification: 80 mg) licensed by Takeda Pharma A/S in healthy subjects under the conditions of single administration on an empty stomach and after a meal. To evaluate whether the two are bioequivalent by the main pharmacokinetic parameters. Secondary objective: To evaluate the safety of Asartan Potassium Tablets by observing the safety indicators of the test preparation and the reference preparation after a single oral administration to healthy subjects.

Start Date15 Oct 2024

Sponsor / Collaborator

Zhuhai Rundu Pharmaceutical Co., Ltd.

CTR20243700

/ CompletedNot Applicable

美阿沙坦钾片在健康受试者中餐后状态下的开放、随机、交叉生物等效性试验

[Translation] An open, randomized, crossover bioequivalence study of Asartan Potassium Tablets in healthy volunteers in the fed state

主要试验目的研究餐后状态下单次口服受试制剂美阿沙坦钾片（规格：80mg，浙江华润三九众益制药有限公司生产）与参比制剂美阿沙坦钾片（商品名：易达比®；规格：80mg；Takeda Ireland Ltd.生产）在健康受试者体内的药代动力学，评价餐后状态口服两种制剂的生物等效性。次要试验目的评估受试制剂美阿沙坦钾片（规格：80mg）与参比制剂易达比®（规格：80mg）在健康受试者中的安全性。

[Translation]

Main study objectives To study the pharmacokinetics of the test preparation, Asartan Potassium Tablets (Specification: 80 mg, produced by Zhejiang China Resources Sanjiu Zhongyi Pharmaceutical Co., Ltd.) and the reference preparation, Asartan Potassium Tablets (trade name: Edabi®; Specification: 80 mg; produced by Takeda Ireland Ltd.) in healthy subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. Secondary study objectives To evaluate the safety of the test preparation, Asartan Potassium Tablets (Specification: 80 mg) and the reference preparation, Edabi® (Specification: 80 mg) in healthy subjects.

Start Date12 Oct 2024

Sponsor / Collaborator

Zhejiang Gaozhi Pharmaceutical Technology Co., LtdStartup

100 Clinical Results associated with Azilsartan Kamedoxomil

100 Translational Medicine associated with Azilsartan Kamedoxomil

100 Patents (Medical) associated with Azilsartan Kamedoxomil

851

Literatures (Medical) associated with Azilsartan Kamedoxomil

01 Mar 2025·Drug Delivery and Translational Research

Multifunctional polymeric nanofibrous scaffolds enriched with azilsartan medoxomil for enhanced wound healing

Article

Author: Singh, Neelu ; Rathore, Kalpana ; Alka ; Ratna, Sheel ; Verma, Vivek ; Verma, Abhishek ; Saraf, Shubhini A ; Mishra, Nidhi ; Singh, Priya ; Nisha, Raquibun

A prolonged and compromised wound healing process poses a significant clinical challenge, necessitating innovative solutions. This research investigates the potential application of nanotechnology-based formulations, specifically nanofiber (NF) scaffolds, in addressing this issue. The study focuses on the development and characterization of multifunctional nanofibrous scaffolds (AZL-CS/PVA-NF) composed of azilsartan medoxomil (AZL) enriched chitosan/polyvinyl alcohol (CS/PVA) through electrospinning. The scaffolds underwent comprehensive characterization both in vitro and in vivo. The mean diameter and tensile strength of AZL-CS/PVA-NF were determined to be 240.42 ± 3.55 nm and 18.05 ± 1.18 MPa, respectively. A notable drug release rate of 93.86 ± 2.04%, was observed from AZL-CS/PVA-NF over 48 h at pH 7.4. Moreover, AZL-CS/PVA-NF exhibited potent antimicrobial efficacy for Staphylococcus aureus and Pseudomonas aeruginosa. The expression levels of Akt and CD31 were significantly elevated, while Stat3 showed a decrease, indicating a heightened tissue regeneration rate with AZL-CS/PVA-NF compared to other treatment groups. In vivo ELISA findings revealed reduced inflammatory markers (IL-6, IL-1β, TNF-α) within treated skin tissue, implying a beneficial effect on injury repair. The comprehensive findings of the present endeavour underscore the superior wound healing activity of the developed AZL-CS/PVA-NF scaffolds in a Wistar rat full-thickness excision wound model. This indicates their potential as novel carriers for drugs and dressings in the field of wound care.

30 Jan 2025·QUINTESSENCE INTERNATIONAL

The effects of photobiomodulation and/or azithromycin treatment on bone resorption biomarkers in gingival crevicular fluid from patients with stage III-IV grade C periodontitis.

Article

Author: Aslan Kehribar, Malike ; Baltacıoğlu, Esra ; Alver, Ahmet ; Dülger, Kıvanç

OBJECTIVES:

This study aimed to investigate the impact of photobiomodulation and/or azithromycin therapy in combination with full-mouth subgingival instrumentation on receptor activator of nuclear factor κB ligand (RANKL) and osteoprotegerin levels and RANKL/osteoprotegerin ratios in gingival crevicular fluid on patients with stage III-IV grade C periodontitis.

METHOD AND MATERIALS:

The study was conducted on 77 stage III-IV grade C periodontitis patients and 20 periodontally healthy controls. Patients with stage III-IV grade C periodontitis were categorized into four treatment groups: 1) only full-mouth subgingival instrumentation (FSI) group; 2) full-mouth subgingival instrumentation + azithromycin (AZM) group; 3) full-mouth subgingival instrumentation + photobiomodulation (PBM) group; and 4) full-mouth subgingival instrumentation + photobiomodulation + azithromycin (AZM+PBM) group. Clinical periodontal parameters and RANKL and osteoprotegerin levels and RANKL/osteoprotegerin ratios in gingival crevicular fluid were measured at baseline and at the third month of therapy.

RESULTS:

Compared with the periodontally healthy controls, all the baseline clinical parameters were higher in the stage III-IV grade C periodontitis groups (P .05); however, there were no statistically significant differences between the stage III-IV grade C periodontitis groups (P > .05). At month 3, the lowest values in all clinical parameters were generally observed in the antibiotics groups, whereas the highest values were observed in the FSI group. Furthermore, the highest RANKL and osteoprotegerin values in antibiotic groups and the highest RANKL/osteoprotegerin ratio in the PBM group were observed in month 3. RANKL/osteoprotegerin ratios did not change in the FSI and antibiotics groups after the treatment, but increased significantly in the PBM group.

CONCLUSION:

While photobiomodulation treatment combined with full-mouth subgingival instrumentation increases the RANKL levels, azithromycin increases osteoprotegerin levels. Also, AZM + PBM treatment shows additional clinical and immunologic beneficial efficacy.

01 Jan 2025·THERIOGENOLOGY

Dexamethasone and azithromycin enhance goat sperm preservation quality by regulating lipid metabolism

Article

Author: Ren, Chunhuan ; Zhang, Zijun ; Cao, Hongguo ; Xu, Yongjie ; Ling, Yinghui ; Sun, Shixin ; Wang, Mingyue ; Shen, Wenzheng ; Wang, Lei

Phospholipase A (PLA) in goat semen aggregates with egg yolk in semen diluent, leading to sperm death. The aim of this study is to address the issue of sperm death caused by the interaction between PLA and egg yolk, and to explore the protective effect and metabolic regulation mechanism of the combination of dexamethasone (DXMS) and azithromycin (AZM) on goat sperm under low temperature conditions. At a low temperature of 4 °C, different concentrations of DXMS were added to semen diluents containing 30 μg/mL AZM to detect the quality of goat sperm. The optimal concentration of DXMS was determined to be 20 μg/mL. On the 5th day of storage, antioxidant capacity, total cholesterol (TC) levels, energy metabolism, and metabolomics analysis were performed on the sperm of the 20 μg/mL DXMS group. The results showed that there was no aggregation caused by the interaction between PLA and egg yolk in the group containing 30 μg/mL AZM at 4 °C. 20 μg/mL DXMS significantly improved sperm motility, plasma membrane integrity, acrosome integrity, glutathione peroxidase (GPX) (P < 0.05), catalase (CAT) (P < 0.01), and superoxide dismutase (SOD) activity (P < 0.01). The content of reactive oxygen species (ROS) and Fe²⁺ significantly decreased (P < 0.01), while the content of ATP (P < 0.01) and TC (P < 0.05) significantly increased. Through metabolomics analysis, a total of 56 differential metabolites (P < 0.05) were screened, including 5a, 6-Anhydrotetracycline, Betamethasone, and 11-Dehydrocorticosterone, mainly enriched in 8 metabolic pathways (P < 0.05), including steroid hormone biosynthesis, glycerophospholipid metabolism, and choline metabolism in cancer. Among them, 5 metabolic pathways are related to lipid metabolism. The results indicate that AZM effectively inhibits the aggregation of PLA and yolk, and the combination of AZM and DXMS enhances the preservation quality of goat sperm during low-temperature preservation by regulating lipid metabolism.

News (Medical) associated with Azilsartan Kamedoxomil

04 Nov 2019

·www.stada.com

STADA invests $660 Million USD in Takeda’s OTC portfolio in Russia/CIS to become a major player in these branded markets

Bad Vilbel, Moscow, November 5, 2019 – STADA Arzneimittel AG (together with its subsidiaries ‘STADA’ or ‘the Group’) has agreed to acquire a portfolio of selected products from Takeda Pharmaceutical Company Limited for a total value of $660 Million USD. The portfolio of approximately 20 selected over-the-counter (‘OTC’) and prescription pharmaceutical assets sold inter alia in Russia, Georgia, Azerbaijan, Belarus, Kazakhstan, and Uzbekistan will be divested to STADA Arzneimittel AG. The portfolio includes OTC-vitamins and food supplements, plus selected products within the cardiovascular, diabetes, general medicine, and respiratory therapeutic areas. Included in the transaction is the key product Cardiomagnyl, a well-known name and category leader in Russia, which is used to prevent blood clots, as well as the newer, patent-protected Nesina (for type II diabetes treatment) and Edarbi (angiotensin II receptor blocker for blood pressure control). The acquired portfolio complements STADA’s existing portfolio and capabilities in Russia which include medicines from 16 of 20 therapeutic groups of the best-selling products in retail pharmacies. The transaction will enable the Group to continue expanding its consumer health business in Russia and the CIS. It is expected that the highly capable approximately 500-strong sales and marketing team from Takeda’s business will transfer to STADA on completion of the transaction, which is expected in the first quarter of 2020. In addition, Takeda and STADA will enter into manufacturing and supply agreements in connection with the acquisition under which Takeda will continue to supply the products to STADA. The acquisition is expected to be financed by new debt financing. Peter Goldschmidt, CEO of STADA, commented: “This is STADA’s largest acquisition to date and will position us as a major player in a large and structurally growing market. This transaction also reflects the ambitions of STADA as we continue expanding the business internationally – both organically and through acquisitions – and continue generating significant operating efficiencies worldwide. STADA’s branded products are already well-represented in the most popular pharmacy categories in our key markets. However, we are continuing to expand our portfolio of branded generics, to strengthen our position in strategic niches and to develop new market segments.” Advisers to STADA on this transaction included: Nomura (M&A) and Kirkland & Ellis LLP (legal). About STADA Arzneimittel AG STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a two pillar strategy consisting of generics, including specialty pharmaceuticals and non-prescription consumer health products. Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries. In financial year 2018, STADA achieved adjusted Group sales of EUR 2,330.8 million and adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 503.5 million. As of December 31, 2018, STADA employed 10,416 people worldwide.

AcquisitionBiosimilar

26 Jul 2017

·www.bioportfolio.com

Arbor Pharmaceuticals LLC Pharmaceuticals Healthcare Deals and Alliances Profile. [Report Updated: 20072017] Prices from USD $250

Summary Arbor Pharmaceuticals LLC Arbor is a healthcare products provider that develops prescription products for the hospital, cardiovascular and pediatric segments. The company offers licensing, manufacturing, development and commercialization of latestage prescription products. It also offers generic prescription and development stage products. Arbor's prescription products comprise edarbi, edarbyclor, bidil, nymalize, eryped, and erythromycin group of products. It offers products used in treatment areas including cardiovascular, emergency, pediatrics, psychiatry and endocrinology diseases. The company offers its products through sales professionals to hospitals and physicians across the US. Arbor is headquartered in Atlanta, Georgia, the US. Arbor Pharmaceuticals LLC Pharmaceuticals Healthcare Deals and Alliances Profile. provides you comprehensive data and trend analysis of the company's Mergers and Acquisitions MAs, partnerships and financings. The report provides detailed information on Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnership transactions recorded by the company over a five year period. The report offers detailed comparative data on the number of deals and their value categorized into deal types, subsector and regions. GlobalData derived the data presented in this report from proprietary inhouse Pharma eTrack deals database, and primary and secondary research. Scope Financial Deals Analysis of the company's financial deals including Mergers and Acquisitions, Equity/Debt Offerings, Private Equity, Venture Financing and Partnerships. Deals by Year Chart and table displaying information encompassing the number of deals and value reported by the company by year, for a five year period. Deals by Type Chart and table depicting information including the number of deals and value reported by the company by type such as Mergers and Acquisitions, Equity/Debt Offering etc. Deals by Region Chart and table presenting information on the number of deals and value reported by the company by region, which includes North America, Europe, Asia Pacific, the Middle East and Africa and South and Central America. Deals by Subsector Chart and table showing information on the number of deals and value reported by the company, by subsector. Major Deals Information on the company's major financial deals. Each such deal has a brief summary, deal type, deal rationale; and deal financials and target Company's major public companies key financial metrics and ratios. Business Description A brief description of the company's operations. Key Employees A list of the key executives of the company. Important Locations and Subsidiaries A list and contact details of key centers of operation and subsidiaries of the company. Key Competitors A list of the key competitors of the company. Key Recent Developments A brief on recent news about the company. Reasons to Buy Get detailed information on the company's financial deals that enable you to understand the company's expansion/divestiture and fund requirements The profile enables you to analyze the company's financial deals by region, by year, by business segments and by type, for a five year period. Understand the company's business segments' expansion / divestiture strategy The profile presents deals from the company's core business segments' perspective to help you understand its corporate strategy. Access elaborate information on the company's recent financial deals that enable you to understand the key deals which have shaped the company Detailed information on major recent deals includes a summary of each deal, deal type, deal rationale, deal financials and Target Company's key financial metrics and ratios. Equip yourself with detailed information about the company's operations to identify potential customers and suppliers. The profile analyzes the company's business structure, locations and subsidiaries, key executives and key competitors. Stay uptodate on the major developments affecting the company Recent developments concerning the company presented in the profile help you track important events. Gain key insights into the company for academic or business research Key elements such as break up of deals into categories and information on detailed major deals are incorporated into the profile to assist your academic or business research needs. Note*: Some sections may be missing if data is unavailable for the company.

Acquisition

100 Deals associated with Azilsartan Kamedoxomil

External Link

KEGG	Wiki	ATC	Drug Bank
-	Azilsartan Kamedoxomil	C09CA09	DB08822

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Essential Hypertension	EU	Takeda Pharma A/S	07 Dec 2011
Essential Hypertension	IS	Takeda Pharma A/S	07 Dec 2011
Essential Hypertension	LI	Takeda Pharma A/S	07 Dec 2011
Essential Hypertension	NO	Takeda Pharma A/S	07 Dec 2011
Hypertension	US	Azurity Pharmaceuticals, Inc.	25 Feb 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	US	Takeda Pharmaceutical Co., Ltd.	01 Jan 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESH2021	Not Applicable	-	-	Fixed-dose combination AZL-M/CLD	ukqwifbnid(lozzdqoymq) = gfvatidjiw dfmuddduds (skasfmnljj, 8.7 - 12.3)	Positive	01 Apr 2021
				Non-fixed-dose combinations of iACE/ARB and thiazide/thiazide-like diuretics	ukqwifbnid(lozzdqoymq) = ytxzanjifm dfmuddduds (skasfmnljj, 9.2 - 12.8)
NCT02541669 (CTgov)	Phase 1	Hypertension	64	TAK-491 (Open Label: TAK-491 40 mg)	aaasoifrvd(noobmjksca) = znkvsxvare geoqkvepzj (brpuqbxmbr, xfvbbmovzo - pvwztjkzjm) View more	-	05 Feb 2020
				TAK-491 (Open Label: TAK-491 80 mg)	aaasoifrvd(noobmjksca) = hgvmkodfii geoqkvepzj (brpuqbxmbr, kpmrjnhblc - omzvvgkxlf) View more
NCT02517866 (CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Essential Hypertension	380	Azilsartan Medoxomil	wyamqidgje(tmebtuahvr) = ombxpfervu jqawplcrnu (sqgvmzfmxb, aimotwmuqy - aoesgtkynr) View more	-	01 Mar 2019
NCT02480764 (CTgov)	Phase 3	Essential Hypertension	612	Valsartan Placebo+Azilsartan medoxomil (Azilsartan Medoxomil 40 mg)	pwacccucpo(slogubgpbe) = drqelfolkt oghleaxtgs (vohgalcnyl, hcploihufr - znqafrenvs) View more	-	11 Feb 2019
				Valsartan Placebo+Azilsartan medoxomil (Azilsartan Medoxomil 80 mg)	pwacccucpo(slogubgpbe) = scveheiamd oghleaxtgs (vohgalcnyl, yozyaevppz - wskedinkzt) View more
NCT00591773 (Pubmed \| J Renin Angiotensin Aldosterone Syst)	Phase 3	Essential Hypertension	551	Azilsartan medoxomil 40 mg plus chlorthalidone	drjpdkeehd(ehuynmazcu) = muyhsotlcc sxnnxbbstd (ysoblykupe )	-	01 Jul 2018
				Azilsartan medoxomil 80 mg plus chlorthalidone	drjpdkeehd(ehuynmazcu) = lzztohkbsq sxnnxbbstd (ysoblykupe )
ESH2018	Not Applicable	Metabolic Syndrome \| Hypertension	32	Azilsartan medoxomil 40 mg	xkuefuzslb(lcyhhskraw) = ihmesunmwo yzpyivgsxy (youqgmhipx ) View more	Positive	01 Jun 2018
				Azilsartan medoxomil 80 mg	xkuefuzslb(lcyhhskraw) = zohaxryypt yzpyivgsxy (youqgmhipx ) View more
[PP.22.13] (ESH2017)	Not Applicable	Essential Hypertension	-	Azilsartan medoxomil 80 mg	nvqubzqggk(xbvqvttrrv) = xsimkpfrez rgqwphntsz (okuhyvauvg, 1.8) View more	Positive	01 Sep 2017
[PP.12.25] (ESH2017)	Not Applicable	Diabetes Mellitus, Type 2 \| Hypertension	30	Azilsartan medoxomil 40 mg	lopbziotwe(ubxhdaqwwk) = vodntvwxpz tdstfbifbw (ywzbefxjmq )	Positive	01 Sep 2017
				Azilsartan medoxomil 80 mg	lopbziotwe(ubxhdaqwwk) = dhznjiqykm tdstfbifbw (ywzbefxjmq )
NCT02203916 (CTgov)	Phase 3	Essential Hypertension	328	Azilsartan medoxomil placebo (Placebo)	gakcsayakk(zxmxfztoem) = jhmgjaqwng spgwceqemm (dldnmgijfn, ogzatfyeev - louzfdawlq) View more	-	19 Dec 2016
				Azilsartan medoxomil (Azilsartan Medoxomil 40 mg)	gakcsayakk(zxmxfztoem) = shjmkxgaov spgwceqemm (dldnmgijfn, gwubmwailt - kpldbsnejc) View more
[PP.01.07] (ESH2016)	Not Applicable	Essential Hypertension	-	Azilsartan medoxomil 80 mg once-daily	xqgktipyxf(mogkrspozh) = xtggjnuslf uabpktgvts (szjrqgwdnn, 1.8) View more	Positive	01 Sep 2016

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