主要研究目的：研究空腹/餐后状态下口服受试制剂精氨酸培哚普利片（江西施美药业股份有限公司生产）与参比制剂精氨酸培哚普利片（COVERSYL®，Les Laboratoires Servier生产）在中国健康成年受试者体内的药代动力学特征，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：评估受试制剂精氨酸培哚普利片和参比制剂精氨酸培哚普利片（COVERSYL®）在中国健康成年受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation Perindopril Arginine Tablets (produced by Jiangxi Shimei Pharmaceutical Co., Ltd.) and the reference preparation Perindopril Arginine Tablets (COVERSYL®, produced by Les Laboratoires Servier) in healthy Chinese adult subjects in the fasting/fed state, and to evaluate the bioequivalence of the two preparations in the fasting/fed state. Secondary purpose of the study is to evaluate the safety of the test preparation Perindopril Arginine Tablets and the reference preparation Perindopril Arginine Tablets (COVERSYL®) in healthy Chinese adult subjects.

Start Date26 Feb 2024

Sponsor / Collaborator

Jiangxi Shimei Pharmaceutical Co., Ltd.

CTR20233406

/ CompletedNot Applicable

精氨酸培哚普利片人体生物等效性研究

[Translation] Study on the bioequivalence of arginine perindopril tablets in healthy volunteers

本试验旨在研究单次空腹和餐后口服石家庄四药有限公司研制、生产的精氨酸培哚普利片（10mg）的药代动力学特征；以Les Laboratoires Servier持证的精氨酸培哚普利片（Coversyl，10mg）为参比制剂，比较两制剂中药动学参数，评价两制剂的人体生物等效性，并观察两制剂在健康受试者中的安全性。

[Translation]

This study aims to study the pharmacokinetic characteristics of a single fasting and postprandial oral administration of arginine perindopril tablets (10 mg) developed and produced by Shijiazhuang Siyao Co., Ltd.; using arginine perindopril tablets (Coversyl, 10 mg) certified by Les Laboratoires Servier as the reference preparation, compare the pharmacokinetic parameters of the two preparations, evaluate the human bioequivalence of the two preparations, and observe the safety of the two preparations in healthy subjects.

Start Date23 Nov 2023

Sponsor / Collaborator

Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

CTR20230504

/ CompletedNot Applicable

一项单中心、随机、开放、单次给药、两制剂、两周期交叉设计研究评价杭州仟源保灵药业有限公司的精氨酸培哚普利片与Les Laboratoires Servier的精氨酸培哚普利片在健康受试者中的空腹和餐后状态下的生物等效性研究

[Translation] A single-center, randomized, open-label, single-dose, two-dose, two-period crossover design study to evaluate the bioequivalence of arginine perindopril tablets from Hangzhou Qianyuan Baoling Pharmaceutical Co., Ltd. and arginine perindopril tablets from Les Laboratoires Servier in healthy subjects under fasting and fed conditions

主要研究目的：评价杭州仟源保灵药业有限公司的精氨酸培哚普利片与Les Laboratoires Servier的精氨酸培哚普利片空腹和餐后单次口服给药后在健康人群中的生物等效性。次要研究目的：评价受试制剂和参比制剂在健康人群中的安全性。

[Translation]

Primary study objective: To evaluate the bioequivalence of the arginine perindopril tablets of Hangzhou Qianyuan Baoling Pharmaceutical Co., Ltd. and the arginine perindopril tablets of Les Laboratoires Servier in healthy subjects after single oral administration on an empty stomach and after meals. Secondary study objective: To evaluate the safety of the test preparation and the reference preparation in healthy subjects.

Start Date13 Feb 2023

Sponsor / Collaborator

Hangzhou QIANYUAN Pollen Pharmaceutical Co., Ltd.

100 Clinical Results associated with Perindopril Arginine

100 Translational Medicine associated with Perindopril Arginine

100 Patents (Medical) associated with Perindopril Arginine

2,120

Literatures (Medical) associated with Perindopril Arginine

01 Feb 2025·Advances in Therapy

Simplified Approach to Managing Newly Diagnosed Patients with Mild-to-Moderate Hypertension in Routine Clinical Practice

Article

Author: Papacostas-Quintanilla, Helena ; on behalf of the Study Investigators ; Daskalopoulou, Stella S. ; Brzozowska-Villatte, Romualda

INTRODUCTIONThe aim of the observational SIMPLE study was to assess real-life effectiveness and safety of a single-pill combination (SPC) of perindopril arginine/amlodipine in a broad range of subjects with newly diagnosed mild-to-moderate hypertension treated in Canadian general practice.METHODSTreatment-naïve participants aged 18-65 years with mild-to-moderate hypertension, whose physicians decided to initiate the perindopril/amlodipine SPC, were recruited from Canadian clinical practice from October 2017 to February 2019. Participants were followed at 3- (M3) and 6-month (M6) visits after treatment initiation. The recommended starting dose of 3.5 mg/2.5 mg once daily was up-titrated, at the discretion of the treating physician, if blood pressure (BP) remained above target at subsequent visits. The primary endpoint was change in mean office systolic BP (SBP) and diastolic BP (DBP) at M6.RESULTSThe full analysis set included 1179 participants with a mean age of 51.5 ± 8.7 years; 61% were male. Mean SBP/DBP at baseline was 153.4 ± 11.5/94.8 ± 7.7 mmHg. Treatment was initiated at 3.5 mg/2.5 mg in 76.0% participants. Over the 6-month treatment period, significant (P < 0.001) decreases from baseline were observed for SBP (- 22.9 ± 14.5 mmHg) and DBP (- 13.4 ± 9.1 mmHg), with 70.2% of participants achieving their BP target. Across all perindopril/amlodipine SPC dose groups, 61.4% of participants achieved BP targets at M3; mean SBP was reduced by 20.8 ± 14.7 mmHg and DBP by 11.7 ± 9.2 mmHg (both P < 0.001). Analysis by baseline subgroup revealed significant BP reductions across age groups, sex, hypertension grades, and diabetes status. Participants with Grade 2 hypertension had a significantly greater decrease than those with Grade 1 (P < 0.001). Treatment with the SPC was well tolerated, and in the 6.1% with treatment-related adverse events, the majority were mild to moderate. High (99%) self-reported adherence (< 20 missed doses) in the 49.4% with available data and high physician satisfaction with treatment (82%) were reported.CONCLUSIONData from routine Canadian clinical practice indicate that a perindopril/amlodipine SPC is associated with significant BP reductions from baseline in a broad range of participants with different cardiovascular risk factors and may represent an appropriate first-line treatment for subjects with newly diagnosed hypertension.

01 Jan 2025·Journal of Chromatography A

Enhancing the practicality along with greenness sustainability of a high throughput HPLC-MS/MS bioanalytical method for the simultaneous determination of amlodipine, perindopril, and its active metabolite perindoprilat in human plasma: Application to a pharmacokinetic study

Article

Author: Elkady, Ehab F ; Sayed, Rawda M ; Moffid, Marwa A ; Mostafa, Eman A

Numerous studies have demonstrated the benefits of amlodipine and perindopril combination therapy in decreasing blood pressure and improving outcomes for high-risk patients. In order to assess the pharmacokinetics of the 2 drugs along with perindoprilat; the active metabolite of perindopril, a simultaneous LC-MS/MS quantification method of amlodipine (AML), perindopril (PER) and perindoprilat (LAT) in human plasma has been developed and validated using amlodipine D4, perindopril D4 and perindoprilat D4 as internal standards (ISs), respectively. A simple and fast protein precipitation method was used to analyze the three analytes from K₃EDTA human plasma. The chromatographic separation included the use of a mixture of methanol and acetonitrile (80:20, v/v) and 0.2 % aqueous formic acid (60:40, v/v) as a mobile phase pumped onto a Zorbax® SB-AQ C18 column. Detection was carried out using a tandem mass spectrometer (MS/MS) in multiple reactions monitoring (MRM) mode. This method exhibited great sensitivity (LLOQ of 0.2 ng/mL for AML and PER and 0.4 ng/mL for LAT), linearity, accuracy (ranging from 97.64 % to 110.28 %), precision (ranging from 2.54 % to 7.60 %), and stability. The method showed good linearity over the range of (0.2-10 ng/mL) for AML, (0.2-160 ng/mL) for PER and (0.4-80 ng/mL) for LAT. The average extraction recoveries of AML, PER and LAT samples were between 81.92 % and 85.07 %. Total elution time was as low as 3 min only. In addition, to ensure the practicality of the developed method, BAGI tool was applied, and the current method has achieved the highest score among the compared methods. Moreover, the sustainability of the proposed method was evaluated using AGREE tool and RGB 12 paradigm showing remarkable sustainability. The developed method is fast, accurate, sensitive, reproducible, ecofriendly, sustainable and suitable for the determination of the concentration of the cited analytes in human plasma. Moreover, it was applied for the bioequivalence study of a generic product to the innovator.

01 Dec 2024·Journal of Chromatography B

Unraveling the molecular mechanism of aqueous extract of Sargentodoxa cuneata against ulcerative colitis from serum metabolomics and bioinformatics perspectives

Article

Author: Wu, Dengli ; Yu, Piao ; Liu, Mei ; Wu, Hongmei ; Xu, Feng ; Wang, Junyi ; Liu, Hongyun ; Wang, Xiangpei

Symptoms of ulcerative colitis (UC) are like "intestinal carbuncle" in Chinese medicine. The aqueous extract of Sargentodoxa cuneata (AESc) has good therapeutic effects on UC, but the underlying mechanism needs to be further elucidated. The mechanism of AESc against UC was studied based on metabolomics and bioinformatics in mice with UC. Dextran sodium sulfate was applied to induce a mouse model of UC. After the intervention of AESc, the general condition of the animals was recorded, and efficacy-related indicators were measured. Information on serum metabolites was determined. Multivariate analysis combined with bioinformatics methods were used to identify the differential metabolites. Furthermore, "metabolite-target-disease" network was obtained, and differential metabolites of UC were screened, and further analysis of the metabolites were performed. Molecular docking validation was also carried out. AESc improved general conditions such as blood in stool, hair of animals, and weight loss, reduced disease activity index scores and shortening of colon length in mice with UC. A total of 3445 serum metabolites were obtained, and 64 differentiated metabolites of AESc against UC were screened. Enrichment analysis showed that arachidonic acid metabolism, bile secretion, drug metabolism-other enzymes, and tyrosine metabolism were associated with AESc in the treatment of UC. In addition, based on "metabolite-target-disease" network, the serum metabolites cholylleucine, 9,10,13-TriHOME, birabresib, anthramycin methyl ether, trans-hexadec-2-enoyl carnitine, and lucidumol A were found to have the therapeutic potential for UC. Further, 14 core targets were obtained, and lipids and atherosclerosis, rheumatoid arthritis and multiple immune-inflammatory pathways were associated with AESc for the treatment of UC. AESc corrects serum metabolic disturbances in UC mice, and multiple serum metabolites have therapeutic potential for UC. AESc may treat UC by regulating biological processes such as lipid metabolism, amino acid metabolism, thereby restoring normal physiological function of the intestine.

News (Medical) associated with Perindopril Arginine

05 Sep 2023

·www.biospace.com

Pharmascience Canada launches a new generic drug to treat hypertension

[05-September-2023] MONTREAL, Sept. 5, 2023 /CNW/ - pms-PERINDOPRIL-INDAPAMIDE (perindopril erbumine / indapamide) is used in adults for the initial treatment of mild to moderate essential hypertension (high blood pressure). pms-PERINDOPRIL-INDAPAMIDE (perindopril erbumine/ indapamide) are a combination of perindopril erbumine, an angiotensin converting enzyme (ACE) inhibitor, and indapamide, a chlorosulphamoyl diuretic. These two active ingredients act synergistically to lower blood pressure in hypertensive patients of all ages. pms-PERINDOPRIL-INDAPAMIDE comes in the following dosage forms: Tablets of 2 mg perindopril erbumine/ 0.625 mg indapamide. Tablets of 4 mg perindopril erbumine/ 1.25 mg indapamide. Tablets of 8 mg perindopril erbumine/ 2.5 mg indapamide. pms-PERINDOPRIL-INDAPAMIDE is a generic equivalent to Coversyl® Plus, Coversyl® Plus LD and Coversyl® Plus HD and has the same safety and efficacy as Coversyl®. pms-PERINDOPRIL-INDAPAMIDE tablets are offered at a lower price than brand-name products. "The Pharmascience team is happy to bring to market pms-Perindopril-Indapamide used for the initial treatment of high blood pressure. The availability of pms-Perindopril-Indapamide gives every Canadian an affordable and important treatment option! At Pharmascience, we take tremendous pride in our locally produced medicines and will continue to focus on growing our portfolio with quality medications needed for all Canadians!" - mentioned Mike Dutton, Vice President, and General Manager of Pharmascience Canada. ABOUT PHARMASCIENCE INC. Founded in 1983, Pharmascience Inc. is the largest pharmaceutical employer in Quebec with 1,500 employees proudly headquartered in Montreal. Pharmascience Inc. is a full-service privately owned pharmaceutical company with strong roots in Canada and a growing global reach with product distribution in over 50 countries. Ranked 50th among Canada's top 100 Research & Development (R&D) investors in 2022, with 40-50 million dollars invested each year, Pharmascience Inc. is among the largest drug manufacturers in Canada. Pharmascience Inc. has strong values based on the importance of investing in its employees and young people. Through various programs and initiatives, the company ensures it supports their personal development and life. In 2023, Pharmascience Inc. has proudly been recognized for its investments by being selected as one of Canada's Top Employers for Young People as part of Canada's Top 100 Employers. Pharmascience is now certified as a Great Place to Work for a second year in a row. For product information, please contact Pharmascience's Medical Information Department at 1-888-550-6060. Coversyl® Plus, Coversyl® Plus LD and Coversyl® Plus HD are registered trademark owned by Servier Canada Inc. SOURCE Pharmascience Inc.

Drug Approval

100 Deals associated with Perindopril Arginine

External Link

KEGG	Wiki	ATC	Drug Bank
-	Perindopril Arginine	C09AA04	DB00790

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Essential Hypertension	China	Les Laboratoires Servier SAS	17 Oct 2014
Coronary Disease	Australia	SERVIER LABORATORIES (AUST.) PTY. LTD.	08 Jun 2005
Heart Failure	Australia	SERVIER LABORATORIES (AUST.) PTY. LTD.	08 Jun 2005
Hypertension	Australia	SERVIER LABORATORIES (AUST.) PTY. LTD.	08 Jun 2005

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01118520 (AARDVARK, CTgov)	Phase 2	Mydriasis \| Aortic Aneurysm, Abdominal	224	perindopril arginine (Perindopril)	rcsrddybzr(irvsftmnue) = plrcuiiauu metmgkahdm (chreeleixm, ivjffgnzvs - cgjshqkrdd) View more	-	26 Jan 2021
				amlodipine 5mgs (Amlodipine)	rcsrddybzr(irvsftmnue) = iicrapfpft metmgkahdm (chreeleixm, horfynqzkp - mpnmazrfun) View more
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)	tnrnyfrvyr(glpepgkeeg) = kpjhlhnbwc incbmgcbwi (zqbnbohawz, fpalrtagib - comzalgvwg) View more	-	11 Dec 2017
				ACEI continuation (ACEI Continuation)	tnrnyfrvyr(glpepgkeeg) = wmkaaxkxtq incbmgcbwi (zqbnbohawz, zkzyrqqizu - ansxdnulnw) View more
OPTITEN (ESH2016)	Not Applicable	-	990	Bisoprolol	orgqkjbswa(wtplemzahf) = ghtoqaogma hqgwypngjx (whupjwsqlv ) View more	Positive	01 Sep 2016
				Perindopril 5 mg	(npbnviemtu) = igbpqccanu xtgomewkvg (dfhtrxigzl ) View more

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