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

2,781

Literatures (Medical) associated with Perindopril Arginine

01 Oct 2025·INTERNATIONAL IMMUNOPHARMACOLOGY

Amlodipine and perindopril modulate miR-874-3p expression to regulate ferroptosis-linked LPCAT3/LACS4/GPX4 Axis and gut dysbiosis in metabolic-associated steatohepatitis

Article

Author: Elmasry, Maryam ; Eltantawy, Eman H ; Hasanin, Amany Helmy ; Ahmed, Manar Fouad ; El-Shafei, Marwa M ; Mohamed, Reham Hussein ; Matboli, Marwa ; Abdelhalim, Marwa Ramadan M ; Hamady, Shaimaa ; Hamam, Ghada Galal

INTRODUCTION:

Metabolic dysfunction-associated fatty liver disease (MAFLD) and its advanced form, metabolic-associated steatohepatitis (MASH), are significant contributors to chronic liver disease. Iron overload, ferroptosis, and intestinal permeability disruptions are critical drivers requiring targeted therapies.

AIM:

This study evaluated the therapeutic effects of amlodipine and perindopril on ferroptosis and intestinal barrier integrity in a diet-induced MASH model and elucidated their mechanistic roles in modulating the miR-874-3p/LPCAT3/LACS4/GPX4 axis identified via bioinformatics.

METHODS:

Male Wistar rats were divided into Sham (normal diet), MASH (high-fat, high-sugar diet), Amlo (MASH + amlodipine), Peri (MASH + perindopril), and Amlo+Peri (combination therapy) groups. Experiments included serum lipid and liver function assays, qPCR for ferroptosis markers (miR-874-3p, LPCAT3, LACS4, GPX4), and evaluation of intestinal permeability (zonulin, TMAO) and occludin expression via immunohistochemistry. Hepatic inflammatory (IL-6), fibrotic (TGF-β1), and apoptotic (caspase-3) markers were analyzed alongside liver and intestinal histopathology.

RESULTS:

Both treatments effectively improved liver function and lipid profiles while reducing inflammatory, fibrotic, and apoptotic markers in MASH rats. Histopathological analysis demonstrated significant reductions in hepatic steatosis, fibrosis, inflammation, and iron deposition. Ferroptosis-related markers showed significant modulation: GPX4 and miR-874-3p were upregulated, while LPCAT3 and LACS4 were downregulated. Intestinal barrier function improved, evidenced by increased intestinal occludin expression and decreased serum zonulin and TMAO levels. Combination therapy exhibited the strongest effects across all parameters.

CONCLUSION:

Amlodipine and perindopril, particularly in combination, effectively modulate the miR-874-3p/LPCAT3/LACS4/GPX4 axis to address ferroptosis and gut dysfunction in MASH, offering promising therapeutic avenues.

01 Sep 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Rapid quantification of 21 antihypertensive and diuretic drugs in plasma by UPLC-MS/MS: Application to clinical and forensic cases

Article

Author: Willeman, Théo ; Boudin, Coralie ; Scolan, Virginie ; Behouche, Alexandre ; Eysseric-Guérin, Hélène ; Stanke-Labesque, Françoise ; Ormezzano, Olivier ; Paysant, François ; Faure, Amandine

Systemic arterial hypertension, affecting more than 1 billion people worldwide, necessitates widespread use of antihypertensive and diuretic medications. However, the potential toxicity related to exposure of these medications is not always fully understood, potentially leading to underestimates of deaths related to cardiovascular drugs. Additionally, the growing interest in monitoring adherence to antihypertensive medications necessitates the development of specific analytical methods suitable for both clinical and forensic applications. In this study, we developed a novel, high-throughput quantitative method for the simultaneous analysis of 21 antihypertensive and diuretic drugs mainly in human plasma using liquid chromatography with tandem mass spectrometry. This method has several advantages, including minimal sample volume requirement, a one-step sample preparation using an Ostro® plate, and a chromatographic run time of 7 min. The method was successfully validated on 11 criteria following the European Medicines Agency's guidances. The method was successfully applied to authentic samples from 62 clinical cases and 76 post-mortem cases, with two cases of severe intoxications more precisely described. The first case describes an attempted suicide by candesartan (2558 ng/mL in plasma) combined with celiprolol (18 ng/mL) and amlodipine (161 ng/mL). The second case is a diuretic-contaminated dietary supplement poisoning with plasma concentrations of 40 ng/mL for furosemide and 36 ng/mL for hydrochlorothiazide. The authors present a simple, fast, and sensitive quantification method for the analysis of 21 antihypertensive and diuretic drugs, with concentration values reported in both living subjects and post-mortem cases to aid in the often-challenging interpretation of cardiotropic drug concentrations.

25 Jul 2025·NATURE MEDICINE

Comparison of dual therapies for hypertension treatment in India: a randomized clinical trial.

Article

Author: Deora, Surender ; Sengupta, Shantanu ; Patil, Satish G ; Senguttuvan, Nagendra Boopathy ; Mishra, Animesh ; Bardoloi, Neil ; Sobitharaj, Edmin Christa ; Kumar, Sunil ; Kiru, Gaia ; Yellapantula, Balsubramaiam ; Sahay, Rakesh Kumar ; Prahalad, Rajpurohit ; Singh, Bhupinder ; Roy, Ambuj ; Singh, Kavita ; Cornelius, Victoria R ; Mukherjee, Somnath ; Aithal, Kiran ; Patil, Suvarna ; Mohan, Bishav ; Salwa, Hyndavi ; Abichandani, Vinod K ; Dandge, Shailendra ; Kondal, Dimple ; Khanna, Mallika ; Chandrasekaran, Ambalam M ; Mahajan, Gayatri ; Prabhakaran, Dorairaj ; Sarvepalli, Vijaya Parthasaradhi ; Poulter, Neil R ; Chavda, Vipul ; Khanna, Aman ; Malviya, Amit ; Lobo, Ameeka Shereen ; Gnanaraj, Justin Paul ; Gupta, Bal Kishan

Evidence is lacking for guiding optimal combination hypertension therapy in South Asian patients. Here we investigated the blood pressure (BP)-lowering efficacy and safety of three commonly recommended antihypertensive dual combinations in a multicenter, single-blinded trial conducted in India. We randomized Indians aged 30-79 years (mean age, 52 years) with mean sitting systolic blood pressure (SBP) of 150-179 mmHg on no treatment or an SBP of 140-159 mmHg on monotherapy 1:1:1 to a single-pill combination of amlodipine-perindopril, perindopril-indapamide or amlodipine-indapamide. The primary outcome was the mean change in 24-hour ambulatory SBP at 6 months. Of the 1,981 participants (42% females) enrolled in the trial, 1,637 completed a 24-hour ambulatory BP measurement. All three drug combinations produced similar large reductions in the primary outcome, namely ambulatory (~14/8 mmHg) and office (~30/14 mmHg) BPs after 6 months, such that hypertension control rates (sitting BP < 140/90 mmHg) were achieved in approximately 70% of participants in all three groups. Furthermore, no significant differences in secondary outcomes, such as mean day and night ambulatory and office BPs and hypertension control rates, were observed among the study groups. Thus, in Indian patients, amlodipine-perindopril, perindopril-indapamide and amlodipine-indapamide were all equally well tolerated and equally highly effective in reducing 24-hour ambulatory and office BPs (ClinicalTrials.gov registration: NCT05683301 ).

News (Medical) associated with Perindopril Arginine

29 Aug 2025

·www.einpresswire.com

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. Alcohol-based hand sanitizers Exposure via inhalation FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. Amlodipine and Levamlodipine Products Azor (amlodipine and olmesartan medoxomil ) Caduet (amlodipine besylate and atorvastatin calcium) Conjupri (levamlodipine maleate) Consensi (amlodipine besylate and celecoxib) Exforge (amlodipine and valsartan) Exforge HCT (amlodipine/valsartan and hydrochlorothiazide) Lotrel (amlodipine besylate and benazepril hydrochloride) Katerzia (amlodipine benzoate) Norvasc (amlodipine besylate) Prestalia (amlodipine besylate and perindopril arginine) Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide) Twynsta (amlodipine and telmisartan) Non-cardiogenic pulmonary edema FDA determined that no action is necessary at the time based on available information. Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) Injection site abscess FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Scleroderma FDA determined that no action is necessary at the time based on available information. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Cholangitis sclerosing The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling Dupixent (dupilumab) Alopecias FDA is evaluating the need for regulatory action. H.P. Acthar Gel (corticotropin) Anaphylactic and anaphylactoid responses The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. Acthar Gel labeling H.P. Acthar Gel (corticotropin) Cardiac arrhythmias The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. Acthar Gel labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) Second primary malignancy FDA determined that no action is necessary at the time based on available information. Lynparza (olaparib) Drug-induced liver injury FDA determined that no action is necessary at the time based on available information. Ocrevus (ocrelizumab) Autoimmune colitis The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. Ocrevus labeling Poteligeo (mogamulizumab-kpkc) Acute kidney injury The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. Poteligeo labeling Ravicti (glycerol phenylbutyrate) Product labeling issue regarding stability and instructions for administration The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. Ravicti labeling Spravato (esketamine) Hypertensive crisis FDA determined that no action is necessary at the time based on available information. Tremfya (guselkumab) Device use errors resulting in possible missed or partial doses The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. Tremfya labeling Trulance (plecanatide) Drug hypersensitivity The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label Trulance (plecanatide) Vomiting The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

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.

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Indication	Country/Location	Organization	Date
Essential Hypertension	China	Les Laboratoires Servier SAS	17 Oct 2014
Coronary Disease	Australia	Servier Laboratories (Australia) Pty Ltd.	08 Jun 2005
Heart Failure	Australia	Servier Laboratories (Australia) Pty Ltd.	08 Jun 2005
Hypertension	Australia	Servier Laboratories (Australia) Pty Ltd.	08 Jun 2005

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01118520 (AARDVARK, CTgov)	Phase 2	Aortic Aneurysm, Abdominal	224	perindopril arginine (Perindopril)	dlodeacgwa(vzaiagbjht) = gjypmfczrw wjmtcvdufv (okcgdmcohv, 0.02) View more	-	26 Jan 2021
				amlodipine 5mgs (Amlodipine)	dlodeacgwa(vzaiagbjht) = efwumhldgj wjmtcvdufv (okcgdmcohv, 0.02) 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)	ictppyiycq = ieikycaenz pbnnptpazw (bdwqrnayus, cgfvkuydkd - pwwllkrxnr) View more	-	11 Dec 2017
				ACEI continuation (ACEI Continuation)	ictppyiycq = dwqqpuqmaq pbnnptpazw (bdwqrnayus, qxqzwvtgyt - ofduyqvucr) View more

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