Delving into the Latest Updates on Azilsartan Kamedoxomil with Synapse

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 / Active, not recruitingNot 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

CTR20243579 / Active, not recruitingNot Applicable

美阿沙坦钾片在健康受试者中空腹/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 subjects under fasting/fed conditions

主要研究目的：研究空腹/餐后状态下单次口服受试制剂美阿沙坦钾片（规格：80mg，陕西白鹿制药股份有限公司生产）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，评价空腹/餐后状态口服两种制剂的生物等效性。次要研究目的：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]

The main purpose of the study is to study the pharmacokinetics of the test preparation, Miasartan Potassium Tablets (Specification: 80 mg, produced by Shaanxi Bailu Pharmaceutical Co., Ltd.) and the reference preparation, Miasartan Potassium Tablets (trade name: Edabi®; Specification: 80 mg; produced by Takeda Ireland Ltd.) in healthy subjects after a single oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary purpose of the study: to evaluate the safety of the test preparation, Miasartan Potassium Tablets (Specification: 80 mg) and the reference preparation, Edabi® (Specification: 80 mg) in healthy subjects.

Start Date09 Oct 2024

Sponsor / Collaborator

Shaanxi BAI LU Pharmaceutical Co. Ltd.

100 Clinical Results associated with Azilsartan Kamedoxomil

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100 Translational Medicine associated with Azilsartan Kamedoxomil

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100 Patents (Medical) associated with Azilsartan Kamedoxomil

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714

Literatures (Medical) associated with Azilsartan Kamedoxomil

01 Jan 2025·Theriogenology

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

Article

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

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.

31 Dec 2024·Journal of Enzyme Inhibition and Medicinal Chemistry

Acetazolamide and human carbonic anhydrases: retrospect, review and discussion of an intimate relationship

Review

Author: Tsikas, Dimitrios

Acetazolamide (AZM) is a strong pharmacological sulphonamide-type (R-SO₂-NH₂, pK_a 7.2) inhibitor of the activity of several carbonic anhydrase (CA) isoforms, notably of renal CA II (K_i, 12 nM) and CA IV (K_i, 74 nM). AZM is clinically used for about eighty years in various diseases including epilepsy and glaucoma. Pharmacological AZM increases temporarily the urinary excretion of bicarbonate (HCO₃^-) and sodium ions (Na⁺) and sustainably the urinary pH. AZM is excreted almost unchanged over several hours at high rates in the urine. Closely parallel concentrations of circulating and excretory AZM are observed upon administration of therapeutical doses of AZM. In a proof-of-principle study, we investigated the effects of the ingestion of a 250-mg AZM-containing tablet by a healthy volunteer on the urinary excretion of organic and inorganic substances over 5 h (range, 0, 0.5, 1, 1.5, 2, 3, 4, 5 h). Measured analytes included: AZM, amino acids and their metabolites such as guanidinoacetate, i.e. the precursor of creatine, of asymmetrically (ADMA) and symmetrically (SDMA) dimethylated arginine, nitrite (O = N-O^-, pK_a 3.4) and nitrate (O₂N-O^-, pK_a -1.37), the major metabolites of nitric oxide (NO), the C-H acidic malondialdehyde (MDA; (CHO)₂CH₂, pK_a 4.5), and creatinine for correction of analytes excretion. All analytes were measured by validated isotopologues using gas chromatography-mass spectrometry (GC-MS) methods. AZM excretion in the urine reached its maximum value after 2 h and was fairly stable for the next 3 h. Time series analysis by the ARIMA method was performed. AZM ingestion increased temporarily the urinary excretion of the amino acids Leu + Ile, nitrite and nitrate, decreased temporarily the urinary excretion of other amino acids. AZM decreased sustainably the urinary excretion of MDA, a biomarker of oxidative stress (i.e. lipid peroxidation). Whether this decrease is due to inhibition of the excretion of MDA or attenuation of oxidative stress by AZM is unknown. The acute and chronic effects of AZM on the urinary excretion of electrolytes and physiological substances reported in the literature are discussed in depth in the light of its extraordinary pharmacokinetics and pharmacodynamics. Tolerance development/drug resistance to AZM in chronic use and potential mechanisms are also addressed.

01 Dec 2024·Advances in Therapy

A Systematic Literature Review and Network Meta-analysis of Azilsartan Medoxomil Compared to Other Anti-hypertensives Efficacy in Lowering Blood Pressure Amongst Mild to Moderate Hypertensive Patients

Review

Author: Zhang, Mengjun ; Chen, Zhangwei ; Qian, Juying

INTRODUCTIONA systematic literature review and network meta-analysis was conducted on azilsartan medoxomil (AZL-M) versus other antihypertensive drugs' efficacy in hypertensive patients.METHODSThe search utilized English platforms, from January 2000 until December 2023, resulting in 10,380 articles being screened. Screening criteria included hypertension (mild or moderate); first-line treatment and washout periods; studies (monotherapy) with AZL-M, angiotensin type II receptor blockers (ARBs), angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor neprilysin inhibitor (ARNIs), beta-blockers, calcium channel blockers (CCBs), and diuretics, either as intervention or comparator; and antihypertension efficacy as an outcome measure. Study design was randomized clinical trials. Efficacy variables included absolute office systolic and diastolic blood pressure (BP) reductions. A total of 21 publications provided adequate data for analysis, of which 20 studies reported both systolic and diastolic BP and one study reported only the diastolic BP.RESULTSIn 21 studies on systolic BP, against the common comparator placebo, the differences in systolic BP were significantly in favor of AZL-M, amlodipine, candesartan, irbesartan, nebivolol, nifedipine, olmesartan, sacubitril valsartan, telmisartan, and valsartan. The surface under the cumulative ranking curve (SUCRA) ranking shows that AZL-M 80 mg had the highest ranking, with a possibility of 93% being the best in all other included treatments. In 20 studies on diastolic BP, against the common comparator placebo, the differences in diastolic BP were significantly in favor of AZL-M, amlodipine, bisoprolol, nebivolol, olmesartan, sacubitril valsartan, telmisartan, and valsartan. The SUCRA ranking shows that AZL-M 80 mg had the highest ranking, with a possibility of 90% being the best in all other included treatments.CONCLUSIONAZL-M at 40 mg and 80 mg shows favorable efficacy compared to other anti-hypertensives, and the 80 mg dosage seemed to be the most efficacious of all the included treatments in reducing both office systolic and diastolic BP in patients with mild-to-moderate hypertension.

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News (Medical) associated with Azilsartan Kamedoxomil

26 Jul 2017

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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

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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
Hypertension	Phase 2	CL	Takeda Pharmaceutical Co., Ltd.	01 Jan 2009
Hypertension	Phase 2	PE	Takeda Pharmaceutical Co., Ltd.	01 Jan 2009
Hypertension	Phase 2	RU	Takeda Pharmaceutical Co., Ltd.	01 Jan 2009
Essential Hypertension	Phase 2	AR	Takeda Pharmaceutical Co., Ltd.	01 Jun 2007
Essential Hypertension	Phase 2	CL	Takeda Pharmaceutical Co., Ltd.	01 Jun 2007
Essential Hypertension	Phase 2	MX	Takeda Pharmaceutical Co., Ltd.	01 Jun 2007
Essential Hypertension	Phase 2	US	Takeda Pharmaceutical Co., Ltd.	01 Jun 2007
Hypertension	Phase 1	RU	Takeda Pharmaceutical Co., Ltd.	01 Jan 2009
Hypertension	Phase 1	CL	Takeda Pharmaceutical Co., Ltd.	01 Jan 2009
Hypertension	Phase 1	PE	Takeda Pharmaceutical Co., Ltd.	01 Jan 2009

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


APAO2024	Not Applicable	Uveitis TNF-α	-	Azithromycin (Sham)	wwgyuziqys(hqpgxzkvrh) = kzjryaaekd lwurhqwkaz (yzxdwjkutl )	Positive	22 Feb 2024
				Topical AZM 1.5%	wwgyuziqys(hqpgxzkvrh) = lhgeqpnyld lwurhqwkaz (yzxdwjkutl )
NCT02541669 (CTgov)	Phase 1	Hypertension	64	TAK-491 (Open Label: TAK-491 40 mg)	xyhqtswnrg(chksoyepts) = hqwsaabckt hsgzcbgvou (wsfaiiszws, lxnnvstpht - hyubuicouh) View more	-	05 Feb 2020
				TAK-491 (Open Label: TAK-491 80 mg)	xyhqtswnrg(chksoyepts) = qnbaaqdoyi hsgzcbgvou (wsfaiiszws, xydhzvfksc - cgtdmyyuyx) View more
NCT02517866 (CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Essential Hypertension	380	Azilsartan Medoxomil	ltsicleyyv(noszalllyq) = abtsocinmm ryebsxjjlh (dqcdhexsoy, veehrfsicv - ncsmzfvcnf) View more	-	01 Mar 2019
NCT02480764 (CTgov)	Phase 3	Essential Hypertension	612	Valsartan Placebo+Azilsartan medoxomil (Azilsartan Medoxomil 40 mg)	rmosepqxzg(ktmzfdboim) = gxozfzjqfj inspwjfpgf (jyzqkakgkh, yhfieihxop - nupzewdytb) View more	-	11 Feb 2019
				Valsartan Placebo+Azilsartan medoxomil (Azilsartan Medoxomil 80 mg)	rmosepqxzg(ktmzfdboim) = zsxwncqevf inspwjfpgf (jyzqkakgkh, dnlvdpvxim - tedfkxclnl) View more
NCT02203916 (CTgov)	Phase 3	Essential Hypertension	328	Azilsartan medoxomil placebo (Placebo)	vecwuxllqa(tgkonrjcnl) = wdacxutyya ptnanjqcgi (ehbllwiswb, mnihtsylhk - zfdiqrkgek) View more	-	19 Dec 2016
				Azilsartan medoxomil (Azilsartan Medoxomil 40 mg)	vecwuxllqa(tgkonrjcnl) = qgoqrvmtlz ptnanjqcgi (ehbllwiswb, wfubbhkmda - dmejgogtoq) View more
NCT00695955 (Pubmed \| Clin Exp Hypertens) Manual	Phase 3	Essential Hypertension	669	chlorthalidone+azilsartan medoxomil	(hhumukfobu) = nroaqzudym bykxhiwuqs (efmetrgmpx ) View more	Positive	01 Jan 2016
				hydrochlorothiazide+azilsartan medoxomil	(hhumukfobu) = umxtcvpmvg bykxhiwuqs (efmetrgmpx ) View more
NCT01496430 (CTgov)	Phase 3	Diabetes Mellitus, Type 2 \| Hypertension	105	Placebo (Placebo QD)	qvuvdwvpon(kvsyaaqjle) = bwbdjooukz hqogbauwqs (einebzytwd, htswtbqzvp - fywraonbbx) View more	-	06 May 2015
				Azilsartan medoxomil (Azilsartan Medoxomil 40 mg QD)	qvuvdwvpon(kvsyaaqjle) = yqlaifnwib hqogbauwqs (einebzytwd, mipbhjqebp - etzgjdagjr) View more
NCT00696384 (Pubmed) Manual	Phase 3	Hypertension	418	Azilsartan Medoxomil	(nbqrnqwztc): difference = -7.8 (95% CI, -9.8 to -5.8), P-Value = <0.001 View more	Positive	01 Mar 2015
				Azilsartan Medoxomil+Chlorthalidone
NCT01078376 (CTgov)	Phase 1	Hypertension	29	Azilsartan medoxomil (TAK-491)	rgflkyojop(ifewthvpne) = bikzxrlyvj vmphmxoswa (smjpllbjil, meqjhdjqha - emwwxixsik) View more	-	25 Jul 2014
ARVO2012	Not Applicable	-	-	Topical AZM	(akhjirhyjz) = The allospecific T cell response was elevated in the AZM treated mice ddrhghkjmv (rafcrgbhvc ) View more	Positive	01 Mar 2012
				Oral AZM