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

Literatures (Medical) associated with Perindopril Arginine

01 Sep 2023·Journal of AOAC International

Chromatographic Techniques for Assessment of Bisoprolol Fumarate and Perindopril Arginine in Solid Formulations under Various Stress Conditions and Application to Six Sigma, Content Uniformity, and Comparative Dissolution Approaches.

Article

Author: Omran, Ahmed A ; Mohamed, Mahmoud A ; Binsaleh, Ammena Y ; Mahmoud, Osama A ; Almalki, Manal A

BACKGROUND:

Antihypertensives bisoprolol fumarate (BIS) and perindopril arginine (PER) were simultaneously determined in their pure, bulk, and combined tablet dosage form.

OBJECTIVE:

This study develops a novel, reproducible, and accurate Reversed phase high-performance liquid chromatography (RP-HPLC) and Reversed phase ultra-performance liquid chromatography (RP-UPLC) with photodiode array detection techniques, which were then applied to in vitro dissolution studies.

METHODS:

The first RP-HPLC method relied on isocratic elution using a mobile phase of methanol-0.05 M phosphate buffer pH 2.6 (1 + 1, by volume), and separation was performed using a Thermo Hypersil C8 column (150 mm × 4.6 mm, 5 μm). Ion-pair UPLC was the second method. An acceptable resolution was achieved using an RP-C18 chromatographic column, Agilent Eclipse (100 × 2.1 mm, 1.7 μm), with a mobile phase containing 0.005 M sodium 1-heptane sulfonate-triethylamine (64 + 1 + 35, by volume), adjusted with phosphoric acid to a pH of 2.0. RP-HPLC used a 1.0 mL/min flow rate, while UPLC used 0.5 mL/min, and the two methods used detection at 210 nm.

RESULTS:

Calibration curves of BIS and PER were linear for RP-HPLC and RP-UPLC methods at 0.5-15 and 0.5-40 μg/mL, respectively. BIS and PER had RP-UPLC LODs of 0.22 and 0.10 μg/mL, respectively, and LOQs of 0.68 and 0.31 μg/mL, respectively. As a result, the approach has been effectively applied to in vitro dissolution testing for drugs in generic and reference products, showing that the two products are comparable. The Six Sigma approach was implemented to compare the recommended and United States Pharmacopeia (USP) procedures, which both exhibited process capability index (Cpk) >1.33. A content uniformity test demonstrated that the drugs in their dosage form met the acceptance limit (85-115%). The degradation products were reliably distinguished from pure drugs for a range of retention times.

CONCLUSION:

In their commercial drug product, the proposed method could be used in QC laboratories for concurrent testing, content uniformity, and in vitro dissolution investigations of BIS and PER. The methods were successfully validated per International Council for Harmonisation (ICH) guidelines.

HIGHLIGHTS:

This study is innovative since it is the first to establish and validate specific and reproducible UPLC and HPLC methods for the concurrent quantitation of the studied drugs in their binary mixture and application to lean Six Sigma, content uniformity, and comparative dissolution approaches.

01 Jun 2022·Advances in therapy

Use of Perindopril Arginine/Indapamide/Amlodipine in the Management of Hypertension in Two Sub-Saharan African Island Countries of Madagascar and Mauritius

Article

Author: Ranivoharisoa, Eliane Mikkelsen ; Ramamonjisoa, Haja Andriamiadanarivo ; Ramilitiana, Benja ; Mbanya, Armand ; Ackbarkhan, Azarkhan ; Mittoo, Mohammad Yaseen ; Ratsimbazafy, Solohery Jean Noël ; Mbanya, Jean Claude

INTRODUCTION:

Most patients with hypertension in sub-Saharan Africa require two or more drugs to control their blood pressure. Triple fixed-dose combination therapy of perindopril arginine/indapamide/amlodipine is more effective in lowering blood pressure, offers better target organ protection and has increased adherence compared to monotherapy and free combination therapy, and is safe to use. This observational study evaluates the effectiveness of perindopril arginine/indapamide/amlodipine in controlling blood pressure at least 1 month after treatment initiation and assesses patient- and physician- reported drug tolerance over a 3-month period in Madagascar and Mauritius.

METHODS:

A total of 198 patients with hypertension in ambulatory care who had been on fixed-dose combination of perindopril arginine, indapamide, and amlodipine for at least 4 weeks were included. The main outcome measures were changes in systolic and diastolic blood pressure, attainment of blood pressure control under 140/90 mmHg and 130/80 mmHg, self-reported drug tolerance by the patient, and perceived drug tolerance by the treating physician. Data was collected at 1 month and 3 months.

RESULTS:

Mean systolic blood pressure was significantly lower at the 1-month (- 3.4 mmHg, p = 0.002) and 3-month (- 8.5 mmHg, p < 0.0001) visits. Diastolic blood pressure also decreased significantly (- 2.4 mmHg at 1-month, p = 0.017 and - 5.4 mmHg at the 3-month visits, p < 0.0001). At 3 months, 80.4% of the patients attained blood pressure targets less than 140/90 mmHg and 42.7% attained targets less than 130/80 mmHg on the basis of their baseline blood pressure. Excellent drug tolerance was reported by more than 90% of patients and physicians at the 1-month visit and by more than 95% at the 3-month visit.

CONCLUSION:

Triple fixed-dose therapy of perindopril arginine/indapamide/amlodipine continues to show additional blood pressure-lowering capacity even months after initiating the treatment in patients with hypertension in Madagascar and Mauritius. It is also well tolerated by patients with hypertension and assessed as safe to use by physicians.

15 Feb 2022·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Advanced chemometric methods as powerful tools for impurity profiling of drug substances and drug products: Application on bisoprolol and perindopril binary mixture.

Article

Author: Elghobashy, Mohamed R ; Abbas, Samah S ; Hassan, Said A ; Moustafa, Azza A ; Nashat, Nancy W

Impurity profiling has a rising importance nowadays due to the increased health problems associated with impurities and degradation products found in several drug substances and formulations. Three advanced, accurate and precise chemometric methods were developed as impurity profiling methods for a mixture of bisoprolol fumarate (BIS) and perindopril arginine (PER) with their degradation products which represent drug impurity or a precursor to such impurity. The methods applied were Partial Least Squares (PLS-1), Multivariate Curve Resolution-Alternating Least Squares (MCR-ALS) and Artificial Neural Networks (ANN). Genetic Algorithm (GA) was used as a variable selection tool to select the most significant wavelengths for the three chemometric models. For proper analysis, a 5-factor 5-level experimental design was used to establish a calibration set of 25 mixtures containing different ratios of the drugs and their degradation products (impurities). The validity of the proposed methods was assessed using an independent validation set. The designed models were able to predict the concentrations of the drugs and the degradation products/impurities in the validation set and pharmaceutical formulation. The proposed methods presented a powerful alternative to traditional and expensive chromatographic methods as impurity profiling tools.

News (Medical) associated with Perindopril Arginine

21 Feb 2024

·www.biospace.com

Discover this new generic drug in the PERINDOPRIL range

MONTREAL, Feb. 21, 2024 /CNW/ - Pharmascience Canada is proud to announce the launch of pms-PERINDOPRIL-AMLODIPINE (perindopril arginine and amlodipine), a drug indicated for the treatment of mild to moderate essential hypertension in adults aged 18 to 65 for whom combination therapy is appropriate. This oral treatment contains two medicines, perindopril arginine and amlodipine. They work together to control the blood pressure. pms-PERINDOPRIL-AMLODIPINE are available in bottles of 100 tablets and comes in the following dosage forms: 3.5 mg / 2.5 mg (this treatment is indicated for initial therapy in patients with mild to moderate essential hypertension.) 7 mg / 5 mg 14 mg / 10 mg This medication is a generic equivalent of Viacoram MD1. pms-PERINDOPRIL-AMLODIPINE tablets are available at affordable prices. « We are excited to introduce Perindopril Amlodipine to the Canadian market, as it reflects our mission to improve the health and quality of life of Canadians through innovative and high-quality products, » said Mike Dutton, Vice-President and General Manager of Pharmascience Canada. « Perindopril Amlodipine is manufactured in our Canadian facility which is another example of how we leverage our expertise and capabilities to deliver value to our customers and patients. » 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 2024, the company was awarded Great Place to Work certification for the third year running. PRVIACORAM®1 is a registered trademark owned by Servier Canada Inc. For product information, please contact Pharmascience's Medical Information Department at 1-888-550-6060. SOURCE Pharmascience Inc.

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	CN	Les Laboratoires Servier SAS	17 Oct 2014
Coronary Disease	AU	SERVIER LABORATORIES (AUST.) PTY. LTD.	08 Jun 2005
Heart Failure	AU	SERVIER LABORATORIES (AUST.) PTY. LTD.	08 Jun 2005
Hypertension	AU	SERVIER LABORATORIES (AUST.) PTY. LTD.	08 Jun 2005

Clinical Result

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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)	hvuvoenjbm(cxwoomgxqr) = dwaoohmrcg exxwkpcgvo (exibcrtgiw, hksujvwdvu - aghneavwjo) View more	-	26 Jan 2021
				amlodipine 5mgs (Amlodipine)	hvuvoenjbm(cxwoomgxqr) = cqqnxsensl exxwkpcgvo (exibcrtgiw, fcurzandgx - qgxgrhnydh) 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)	ohufxaalfc(cuebnjwugf) = wwubprvrlx htyztsasor (cvruvnlmky, qlmvkwpymy - kviwegxrln) View more	-	11 Dec 2017
				ACEI continuation (ACEI Continuation)	ohufxaalfc(cuebnjwugf) = ovdcijtabn htyztsasor (cvruvnlmky, lexvglqkfk - coinkblzww) View more

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