[Translation] A randomized, open-label, single-dose bioequivalence comparison study of benazepril hydrochloride tablets in healthy Chinese adult subjects after fasting and feeding

1)主要目的评价北京阳光诺和药物研究股份有限公司持有的盐酸贝那普利片受试制剂（T）与北京诺华制药有限公司生产的盐酸贝那普利片（商品名：洛汀新？）参比制剂（R）在健康人体中吸收速度和吸收程度是否具有一致性；观察指标：Cmax、AUC0-t、AUC0-∞、Tmax、λz、t1/2 2)次要目的观察受试制剂和参比制剂在健康受试者中的安全性。观察指标：不良事件/反应发生情况。

[Translation]

1) Main purpose To evaluate whether the absorption rate and degree of the test preparation (T) of Benazepril Hydrochloride Tablets held by Beijing Sunshine Novo Pharmaceutical Research Co., Ltd. and the reference preparation (R) of Benazepril Hydrochloride Tablets (trade name: Lotensin?) produced by Beijing Novartis Pharmaceutical Co., Ltd. are consistent in healthy human bodies; Observation indicators: Cmax, AUC0-t, AUC0-∞, Tmax, λz, t1/2 2) Secondary purpose To observe the safety of the test preparation and the reference preparation in healthy subjects. Observation indicators: Occurrence of adverse events/reactions.

Start Date25 Jun 2022

Sponsor / Collaborator

Beijing Sun-Novo Pharmaceutical Research Co., Ltd.

CTR20212705 / Active, not recruitingNot Applicable

盐酸贝那普利片在中国成年健康受试者中的一项单中心、随机、开放、空腹和餐后单次给药、两制剂、两序列、两周期交叉的生物等效性研究

[Translation] A single-center, randomized, open-label, single-dose, fasting and postprandial, two-formulation, two-sequence, two-period crossover bioequivalence study of benazepril hydrochloride tablets in healthy Chinese adult subjects

主要研究目的：考察单次单剂量口服（空腹/餐后）受试制剂盐酸贝那普利片（规格：10mg/片，北京百奥药业有限责任公司生产）与参比制剂盐酸贝那普利片（洛汀新®，规格：10mg/片，北京诺华制药有限公司生产），在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为该药的申报及临床用药提供参考依据。次要研究目的：评价空腹、餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。

[Translation]

The main purpose of the study is to investigate the relative bioavailability of the test preparation benazepril hydrochloride tablets (specification: 10 mg/tablet, produced by Beijing Biopharma Co., Ltd.) and the reference preparation benazepril hydrochloride tablets (Lotensin®, specification: 10 mg/tablet, produced by Beijing Novartis Pharmaceuticals Co., Ltd.) in healthy Chinese subjects after a single oral dose (fasting/postprandial) and to analyze the pharmacokinetic parameters of the two preparations and to evaluate the bioequivalence of the two preparations, so as to provide a reference for the application and clinical use of the drug. The secondary purpose of the study is to evaluate the safety of the test preparation and the reference preparation in healthy Chinese adult subjects after a single oral dose (fasting/postprandial).

Start Date09 Nov 2021

Sponsor / Collaborator

Beijing Sun-Novo Pharmaceutical Research Co., Ltd.

NCT04937907 / RecruitingPhase 2IIT

Efficacy and Safety of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS)

This Phase 2 randomized controlled trial will study the safety, tolerability, and efficacy of Hydroxychloroquine in qualified patients with Alport syndrome. The trial will be open-label, randomized, controlled and will enroll up to 50 patients.

Start Date08 Sep 2021

Sponsor / Collaborator-

100 Clinical Results associated with Benazepril Hydrochloride

100 Translational Medicine associated with Benazepril Hydrochloride

100 Patents (Medical) associated with Benazepril Hydrochloride

833

Literatures (Medical) associated with Benazepril Hydrochloride

01 Dec 2024·Contemporary Clinical Trials Communications

A clinical randomized trial: Effects of early application of sacubitril/valsartan on ventricular remodeling and prognosis in acute myocardial infarction patients

Article

Author: Liu, Zhengfeng ; Wang, Guangdong ; Cui, Kun ; Zhang, Yuanzheng ; Yao, Qiong ; Jin, Wenqing

ObjectivesTo explore the effects of early application of sacubitril/valsartan on ventricular remodeling and prognosis in patients with acute myocardial infarction (AMI).MethodsTotal of 295 patients with AMI admitted to the hospital were enrolled between August 2019 and August 2021. According to different treatment methods, they were divided into observation group (sacubitril/valsartan sodium tables combined with standard treatment, 132 patients) and control group (benazepril hydrochloride tablets combined with standard treatment, 163 patients). The levels of plasma N-terminal pro-brain natriuretic peptide (NT-proBNP), creatinine (Cr) and serum K⁺ before and at 6 months after treatment, standard deviation of all normal-to-normal intervals (SDNN), standard deviation of the average all normal-to-normal intervals (SDANN), root mean square of differences between adjacent normal-to-normal intervals/root mean square differences of successive R-R (RMSSD), left ventricular end-diastolic volume (LVEDV), left ventricular ejection fraction (LVEF) and left ventricular end-systolic volume (LVESV) in the two groups were compared. The adverse reactions during treatment and major adverse cardiac events (MACE) during 6 months of follow-up in both groups were statistically analyzed.ResultsThe levels of NT-proBNP, Cr and K⁺, LVEDV and LVESV in observation group were significantly lower than those in control group (P < 0.05), while LVEF, SDNN, SDANN and RMSSD were significantly higher than those in control group (P < 0.05). The incidence of MACE in observation group was lower than that in control group during 6 months of follow-up (7.58 % vs 27.61 %, P < 0.05), but there was no significant difference in the incidence of adverse reactions (9.85 % vs 12.88 %, P > 0.05).ConclusionEarly application of sacubitril/valsartan sodium can effectively delay ventricular remodeling, improve cardiac function and heart rate variability indexes, reduce NT-proBNP level and improve prognosis in AMI patients.

01 Oct 2024·Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan

Effect of phosphatase and tensin homolog-induced putative kinase 1/ E3 ubiquitin ligase Parkin mediated mitochondrial autophagy on chronic kidney disease myocardial injury and the intervention mechanism of Shenshuai recipe.

Article

Author: Gedi, Zhang ; Fuli, Luo ; Ziyou, Yan ; Min, Guo ; Wei, G E ; Gengxin, Liu

OBJECTIVETo study whether Shenshuai recipe (, SSR) can play a protective role on chronic kidney disease myocardial injury model through phosphatase and tensin homolog-induced putative kinase 1 (PINK1)/E3 ubiquitin ligase Parkin (Parkin) mitochondrial autophagy pathway.METHODSForty-eight nephrectomized rats were randomly divided into six groups: sham-operated group, model group, Benazepril group, low, medium and high-dose groups of SSR. The rats were given the cor-responding intervention for six weeks, then were sacrificed. Serum was examined by enzyme linked immunosorbent assay (ELISA). Cardiac ultrasound was used to detect cardiac function in 5/6 nephrectomized rats. Myocardial tissue was examined by light and electron microscopy; PINK1, Parkin, microtubule-associated protein1 light chain 3 II (LC3B), sequestosome 1 (P62), BECN1 (Beclin-1) and dynamin-related protein 1 (Drp-1) were measured by real time polymerase chain reaction (RT-PCR), Western blot (WB) and immunohistochemistry (IHC).RESULTSThe expression levels of blood urea nitrogen (BUN) and creatinine (SCr) in the model group were significantly higher than those in the sham-operated group, indicating that modeling was successful. SSR can protect myocardium by reducing the relative expression of creatine kinase myocardial isoenzyme and hypersensitivity cardiac troponin I (P<0.05). SSR can improve cardiac function in rats after ultrasound testing. SSR can improve the pathological manifestations of myocardial tissue after Masson staining. SSR can increase the number of autophagosomes and autophagiclysosomes in 5/6 nephrectomized rats (P<0.05). Determined by RT-PCR, WB and IHC, SSR can increase the relative expression of PINK1, Parkin, and LC3B (P<0.05), and decrease the relative expression of P62, Beclin-1 and Drp-1 (P<0.05).CONCLUSIONSThe PINK1/Parkin mitochondrial autophagy pathway in myocardial tissues in 5/6 nephrectomy CKD myocardial injury rats was inhibited. SSR can activate PINK1/Parkin mitochondrial autophagy to enhance mitochondrial autophagy, and play a protective role in myocardial tissues.

06 Aug 2024·Journal of the American Heart Association

Acute Declines in Estimated Glomerular Filtration Rate in Patients Treated With Benazepril and Hydrochlorothiazide Versus Amlodipine and Risk of Cardiovascular Outcomes

Article

Author: Copeland, Timothy P ; Ku, Elaine ; Jamerson, Kenneth ; Tighiouart, Hocine ; Sarnak, Mark J ; McCulloch, Charles E

BackgroundAcute declines in estimated glomerular filtration rate (eGFR) occur commonly after starting angiotensin‐converting enzyme inhibitors. Whether declines in eGFR that occur after simultaneously starting angiotensin‐converting enzyme inhibitors with other antihypertensive agents modifies the benefits of these agents on cardiovascular outcomes is unclear.Methods and ResultsWe identified predictors of acute declines in eGFR (>15% over 3 months) during randomization to benazepril plus amlodipine versus benazepril plus hydrochlorothiazide in the ACCOMPLISH (Avoiding Cardiovascular Events through Combination Therapy in Patients Living with Systolic Hypertension) trial. We then determined the relation between declines in eGFR (treated as a binary variable, ≤15% versus >15% and separately, as a restricted spline variable) and the composite risk of fatal and nonfatal cardiovascular events using Cox proportional hazards models. We included 10 714 participants (median age 68 years [Q1 63, Q3 73]), of whom 1024 reached the trial end point over median follow‐up of 2.8 years. Predictors of acute declines in eGFR>15% over 3 months included assignment to hydrochlorothiazide (versus amlodipine) and higher baseline albuminuria. Overall, declines in eGFR ≥15% (versus <15%) were associated with a 26% higher hazard of cardiovascular outcomes (95% CI, 1.07–1.48). In spline‐based analysis, risk for cardiovascular outcomes was higher in the hydrochlorothiazide arm at every level of decline in eGFR compared with the same magnitude of eGFR decline in the amlodipine arm.ConclusionCombined use of benazepril and amlodipine remains superior to benazepril and hydrochlorothiazide for cardiovascular outcomes, regardless of the magnitude of the decline in eGFR that occurred with initiation of therapy.

News (Medical) associated with Benazepril Hydrochloride

14 May 2024

·www.prnewswire.com

CardioPharma Announces Issuance of Global Patent to Mitigate the World's Top Killer

WILMINGTON, N.C., May 14, 2024 /PRNewswire/ -- CardioPharma Inc. (the "Company"), a specialty pharmaceutical company focused on drug development for cardiovascular diseases, announced that on August 29, 2023, the United States Patent and Trademark Office ("USPTO") issued US Patent 11,737,988 B2 entitled "Anti-Hypertensive and Cholesterol-Lowering Fixed-Dose Combination and Method of Manufacture." Additional patents covering the subject matter of the '988 Patent have been granted in South Africa in 2022 and Australia, Armenia, Belarus, and the Russian Federation in 2024. Three further patents have been accepted in Canada, New Zealand, and Israel and will issue in the near future. In addition to the foregoing, CardioPharma is pursuing additional patents in major markets throughout the world, all of which together will bolster CardioPharma's global presence for the products covered by the patent grants. The 20-year term for all of the patents runs through April 17, 2039. CardioPharma Pipeline CardioPharma's pipeline products contain some of the world's most consumed, individually dispensed medications for the prevention and treatment of cardiovascular disease. The lead product, CardiaPill® is a unique formulation combining a cholesterol modifying agent ("statin"), an Angiotensin-converting-enzyme inhibitor (ACE Inhibitor) and anti-platelet agent. Statins moderate cholesterol levels and include products such as Lipitor®, Zocor®, Pravachol®; and Crestor®. ACE inhibitors reduce blood pressure and include products such as Altace®, Lotensin®, Capoten® and Accupril®. Pipeline products also include combinations using Angiotensin II Receptor Blockers (ARBs) as well as different statins and other anti-platelet agents. Simplicity of dosing, improved adherence and significant cost benefits for patients, providers and payors around the world are among the many compelling and well-documented benefits that make these inexpensive products so anticipated. About CardioPharma CardioPharma (), Inc. is a specialty pharmaceutical company focused on patent-protected combinatorial cardiovascular medications. CardioPharma's goal is to create drugs that make it easier and more cost-effective for doctors and their patients to reduce the morbidity and mortality of the world's number one killer – cardiovascular disease. The products are unique to the global pharmaceutical industry – highly cost-effective with proven efficacy; providing both patient and provider convenience; promoting adherence, while delivering superior clinical outcomes and economic benefits to all stakeholders. For more information, visit . Forward looking statements The information in this press release contains forward-looking statements including the prospective development, commercialization and regulatory approval in the U.S. and international markets. Words such as "expects," "plans," "believe," "may," "will," "anticipated," "intended" and variations of these words or similar expressions are intended to identify forward-looking statements. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors including the Company's ability to raise sufficient funds to bring new products to the global market. Contact: [email protected] SOURCE CardioPharma, Inc.

Patent Expiration

26 Feb 2021

·www.biospace.com

How Demand for Renovascular Hypertension Treatment Growth Spurred by Increasing Prevalence of Kidney Disorders, Opines Fact.MR

Fact.MR, a global research & consulting firm, in their latest edition of the report, projected that the renovascular hypertension treatment market is anticipated to see moderate growth pace in 2021 and beyond. Increase in initiatives undertaken by private and public healthcare organisations for the management of kidney diseases, which will spearhead the expansion of the renovascular hypertension treatment industry. “Renovascular hypertension treatment industry will be growing moderately due to increase in the occurrence of primary renal ailments, such as focal segmental glomerulosclerosis, atherosclerosis and renal artery stenosis.” states Fact.MR. Changing Lifestyle of People Influencing Industry Growth Unhealthy lifestyle, obesity, stress, rise in smoking and the higher prevalence of cholesterols & diabetes are amid aspects projected to drive the renovascular hypertension treatment industry. Furthermore, increased consumption of ready-to-eat food products, as well as absence of physical activity of individuals, upsurge the chances for high blood pressure and hypertension. Several researches and studies have revealed a clear link between rise in blood pressure and the consumption of high levels of salt. Request a report sample to gain comprehensive market insights at - Why is Demand from ACE inhibitors More? Angiotensin-Converting Enzyme (ACE) inhibitor will be contributing majority of the revenue share in the approaching years. ACE inhibitors given for the treatment of renovascular hypertension intrude the adaptation of angiotensin I and angiotensin II. Enalapril, captopril, ramipril, lisinopril, and benazepril are the general ACE inhibitors utilized for treatment of renovascular hypertension. In addition to ACE inhibitors, diuretic drugs and angiotensin II receptor blockers are also prescribed by healthcare professionals for the kidney to remove fluid from the blood. What are the Factors Responsible for Industry Growth in the US? The US has been found to hold a major share for the renovascular hypertension treatment owing to exceedingly supportive government initiatives. Also majority of market players have been attaining approval for the clinical trials from the FDA, in the region. Germany and the UK are anticipated to have the second-biggest share due to the increasing awareness pertaining to major health issues registered for drug-resistant hypertension. Emerging regions such as China, India and South Korea is likely to catch up with the progressions in healthcare infrastructure, as well as rise in healthcare expenditure and facilities. Moreover, the existence of a huge target population base in economies such as China and Japan are the main drivers for renovascular hypertension treatment. Get Customization on this Report for Specific Country New Drug Development Remain Key Focus Area: Fact.MR Survey The renovascular hypertension treatment market appears consolidated. Fact.MR’s survey reflected that the major companies are engaged in conducting clinical trials for development of novel treatment drugs for renovascular hypertension. The updated edition of the report offer all-inclusive coverage of the anticipated to remain significant strategies of the companies. A few of the key companies profiled in the report are Pfizer Inc., Abbott Laboratories, Novartis AG, AstraZeneca plc., Merck & Company, Inc., Johnson and Johnson, Sanofi SA, Eli Lilly and Company, Bayer AG, Teva Pharmaceutical Industries Ltd., GlaxoSmithKline plc, and others. The latest edition also provides a comprehensive analysis of the COVID-19 impact on this market. Explore Fact.MR’s Healthcare Reports Atherosclerotic Renovascular Treatment Market: Delve into Fact.MR’s extensive study on the atherosclerotic renovascular treatment market, offering detailed assessment. The study analyses crucial trends that are currently determining, and those which are expected to shape future expansion trajectory, shedding light on the vital dynamics such as drivers, restraints and opportunities. Renal Artery Stenosis Treatment Market: The global renal artery stenosis treatment market study published by fact.mr incorporates detailed assessment of the market landscape, taking into consideration value chain analysis, business execution and supply chain analysis across key markets. Renal Drugs Market: Fact.MR’s global renal drugs market research report provides stakeholders with an exhaustive analysis on key market dynamics, such as the drivers, restraints, opportunities and trends responsible for shaping the future expansion trajectory. About Fact.MR Market research and consulting agency with a difference! That’s why 80% of Fortune 1,000 companies trust us for making their most critical decisions. We have offices in US and Dublin, whereas our global headquarter is in Dubai. While our experienced consultants employ the latest technologies to extract hard-to-find insights, we believe our USP is the trust clients have on our expertise. Spanning a wide range – from automotive & industry 4.0 to healthcare & retail, our coverage is expansive, but we ensure even the most niche categories are analyzed. Reach out to us with your goals, and we’ll be an able research partner. Contact: Sudip Saha US Sales Office: 11140 Rockville Pike Suite 400 Rockville, MD 20852 United States Tel: +1 (628) 251-1583 E: sales@factmr.com Corporate Headquarter: Unit No: AU-01-H Gold Tower (AU), Plot No: JLT-PH1-I3A, Jumeirah Lakes Towers, Dubai, United Arab Emirates Source: Fact.MR

21 May 2007

·www.biospace.com

Teva Pharmaceutical Industries Limited Provides Update on Generic Lotrel® Litigation

JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the United States District Court for the District of New Jersey has vacated a temporary order restraining Teva's launch of its amlodipine besylate/benazepril products, AB rated to Novartis' Lotrel®. Instead, the Court has ordered Teva and Novartis not to sell or offer further generic product, beyond what has already been commercialized, including any authorized generics, until at least the completion of a status call with the Judge next Tuesday, May 29, 2007.

Generic Drug

100 Deals associated with Benazepril Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D00620	Benazepril Hydrochloride	C09AA07	DB00542

R&D Status

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Indication	Country/Location	Organization	Date
Hypertension	US	Validus Pharmaceuticals LLC	25 Jun 1991

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01669434 (CTgov)	Phase 4	Hypotension	291	LISINOPRIL+Captopril+ENALAPRILAT+BENAZEPRIL HYDROCHLORIDE+PERINDOPRIL ERBUMINE+RAMIPRIL+QUINAPRIL HYDROCHLORIDE+Enalapril Maleate+Perindopril Arginine+FOSINOPRIL SODIUM+TRANDOLAPRIL+MOEXIPRIL HYDROCHLORIDE (ACEI Omission)	vnimjdblre(sgvdnbwwdr) = wzwbujbezl ovhtwjmohu (cqjmgojewu, scbakeyzyw - uytiiggvvb) View more	-	11 Dec 2017
				ACEI continuation (ACEI Continuation)	vnimjdblre(sgvdnbwwdr) = ctwkqrgebh ovhtwjmohu (cqjmgojewu, psgnjedzpi - dswwczxgeg) View more
NCT01603940 (CONTROL, CTgov)	Phase 4	Diabetes Mellitus \| Hypertension	30	Losartan (Losartan)	(imqyqhsegj) = abjtfnttdt wqeuqyssng (ddympeuogm, uprbdvnavv - wtvpqidany) View more	-	11 Nov 2015
				Benazepril (Benazepril)	(imqyqhsegj) = xephgymmvm wqeuqyssng (ddympeuogm, dswjhihwdn - izfroyyvre) View more
NCT01234922 (CTgov)	Phase 2	Solid tumor \| Hypertension	6	laboratory biomarker analysis+benazepril hydrochloride (Arm I)	puvjpwusyt(nmnuowpvud) = yaclnbigwg lzovdkwypi (qetmumklow, jhxsibgolm - tllpguozei) View more	-	15 Dec 2014
				lisinopril+laboratory biomarker analysis (Arm II)	puvjpwusyt(nmnuowpvud) = pwrlguuxci lzovdkwypi (qetmumklow, dbunajxjlm - qvhfuqudkg) View more
NCT00318474 (CTgov)	Phase 3	Glomerulonephritis, IGA	184	ACEi+FOS+Mycophenolate Mofetil (MMF)	byxjuekwos(spyepdxmzf) = jdcaytrsed ehtzlzrrbw (xkonvqwkrw, ktpfppgvcv - vmowxuvqrg) View more	-	01 Oct 2014
NCT00907374 (END-IT, CTgov)	Not Applicable	Kidney Diseases \| Diabetes Mellitus	46	benazepril (Low Dose Inhibition of RAS)	teiqbcpvsf(nyayhjrtwn) = vtutatzlim harvqtowrz (mdzjexxmmp, xfhxfmczyh - tsjnolunka) View more	-	30 Mar 2012
				benazepril (Agressive Inhibition of the RAS)	teiqbcpvsf(nyayhjrtwn) = gnprexfvxq harvqtowrz (mdzjexxmmp, ykvmedpbhd - kbojfssqmy) View more

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