[Translation] An open, randomized, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of perindopril tert-butylamine tablets in healthy participants under fasting conditions

研究空腹状态下单次口服受试制剂（培哚普利叔丁胺片，规格8mg，华益药业科技（安徽）有限公司持证）与参比制剂（培哚普利叔丁胺片，规格8mg，商品名雅施达®，施维雅（天津）制药有限公司持证）在健康参与者体内的药代动力学特征，比较受试制剂与参比制剂的生物等效性，并研究药物在健康参与者体内的安全性。

[Translation]

To study the pharmacokinetic characteristics of a single oral dose of the test preparation (Perindopril tert-butylamine tablets, specification 8 mg, licensed by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.) and the reference preparation (Perindopril tert-butylamine tablets, specification 8 mg, trade name Yashida®, licensed by Servier (Tianjin) Pharmaceutical Co., Ltd.) in healthy participants under fasting state, to compare the bioequivalence of the test preparation and the reference preparation, and to study the safety of the drug in healthy participants.

Start Date23 Dec 2024

Sponsor / Collaborator

Huayi Pharmaceutical Technology (Anhui) Co., Ltd.

ACTRN12624000648527

/ Not yet recruitingPhase 4IIT

FAN Trial: A randomised controlled open label trial assessing the effect of perindopril erbumine on Fontan-Associated Nephropathy in adults and children 5 years or older.

Start Date01 Jun 2024

Sponsor / Collaborator-

NCT06341101

/ RecruitingPhase 4IIT

Timely Recovery After Subclinical Heart Failure (TREASURE Trial)

The goal of this randomized controlled trial is to assess the effectiveness of ACE inhibitors versus standard care) in reversing asymptomatic heart failure (HF stage-B) and/or diastolic dysfunction during a two-year open-label treatment period for formerly preeclamptic women on:
Reversibility of structural and functional myocardial impairment in asymptomatic HF towards healthy values;
The progression from asymptomatic to symptomatic HF (symptoms scored based on the NYHA criteria);
Cardiovascular performance (volume- and pressure load), cardio metabolic risk factors (glucose metabolism, lipid status, kidney function) and quality of life (questionnaires);
Novel biomarkers and relevant microRNA's indicative for hypertrophy, fibrosis inflammation and ischemia.
Eligible subjects will be counselled and upon informed consent randomized for either medication group (n=65) or care as usual group (n=65). After a complete cardiovascular assessment, medication will be initiated open-labeled (Perindopril 2 mg or no medication). Thereafter, standard medical check-ups (blood pressure, ECG, kidney function, transthoracic cardiac ultrasound, endothelial function, quality of life questionnaires, medical history taking, blood and urine banking) will be performed every six months for two years.
Researchers will compare ACE inhibitor (Perindopril 2 mg) and care as usual (i.e. no medication) to investigate whether ACE inhibitor allows timely recovery after subclinical heart failure.

Start Date26 Mar 2024

Sponsor / Collaborator

Academisch Ziekenhuis Maastricht

[+1]

100 Clinical Results associated with Perindopril Erbumine

100 Translational Medicine associated with Perindopril Erbumine

100 Patents (Medical) associated with Perindopril Erbumine

3,503

Literatures (Medical) associated with Perindopril Erbumine

01 Apr 2025·Journal of Ethnopharmacology

Xinyin tablets affect mitophagy and cardiomyocyte apoptosis to alleviate chronic heart failure by regulating histone deacetylase 3(HDAC3)-mediated PTEN induced putative kinase 1(PINK1)/Parkin signaling pathway

Article

Author: Chen, Pinliang ; Guo, Zhenyu ; Guo, Pengpeng ; Zhou, Xiaoxiong ; Feng, Ruoshui ; Chen, Qiucen ; Chen, Hanyu ; Lin, Qianbei ; Kang, Jinhua ; Zeng, Yanlin

ETHNOPHARMACOLOGICAL RELEVANCEXinyin tablets, Chinese patent medicine, are composed of Panax ginseng C.A.Mey. (Araliaceae), Ilex pubescens Hook. & Arn. (Aquifoliaceae), Leonurus japonicus Houtt. (Lamiaceae), Plantago asiatica L. (Plantaginaceae), Ophiopogon japonicus (Thunb.) Ker Gawl. (Asparagaceae), Astragalus membranaceus (Fisch.) Bunge, and Draba nemorosa L. (Brassicaceae). It has been used for the prevention and treatment of chronic heart failure (CHF) clinically. However, its underlying mechanism of action is far from completely understood.AIM OF THE STUDYThis study aimed to determine whether Xinyin tablets alleviate CHF in SPF C57 mice and to explore the potential mechanism of action in H9c2 cells.MATERIALS AND METHODSLiquid chromatography tandem mass spectroscopy (LC-MS/MS) was performed to identify the chemical compounds in Xinyin tablets. In vivo, 60 C57 mice were randomly divided into 6 groups: the sham group; model group; low-, medium-, and high-dose Xinyin tablets groups; and perindopril group. Animals in the sham group underwent thoracotomy only. The others were subjected to coronary artery ligation. After 4 weeks of drug intervention, the cardiac function of the mice in each group was detected via echocardiography, the myocardial cells were evaluated via HE staining, and the degree of myocardial fibrosis was detected via Masson's trichrome staining. The expression of PINK1/Parkin signaling pathway-related genes (HDAC3, PINK1, Parkin, P62, LC3II/I, caspase-3, caspase-9, and Bax) was analyzed via RT‒qPCR and Western blotting. The effects of Xinyin tablets on cardiomyocyte apoptosis and mitophagy mediated by the HDAC3 and PINK1/Parkin pathways in CHF model mice were evaluated. In vitro, H9c2 cardiomyocytes subjected to hypoxia were treated with different concentrations of Xinyin tablets. The mRNA transcription levels of HDAC3, PINK1, Parkin, P62, LC3II/I, caspase-3, caspase-9, and Bax were measured via fluorescence quantitative PCR. Western blotting was used to detect the protein expression levels of PINK1, Parkin, P62, LC3 II/I, caspase-3, caspase-9, and Bax. TUNEL staining was used to detect the number of apoptotic bodies in the myocardium to evaluate the level of apoptosis. Transmission electron microscopy was used to observe changes in the number of mitophagosomes. Rapamycin (mitophagy agonist), Mdivi-1 (mitophagy inhibitor), ITSA-1 (HDAC3 agonist) and RGFP966 (HDAC3 inhibitor) were used to create intervention conditions. The effects of rapamycin or Mdivi-1 on PINK1/Parkin-mediated mitophagy were observed. Then, the effects of HDAC3 on the PINK1/Parkin signaling pathway, mitophagy and apoptosis in hypoxic cardiomyocytes were observed. Hypoxic cardiomyocytes were treated with Xinyin tablets-containing serum or control serum to observe whether Xinyin tablets could still play a protective role in cardiomyocytes when HDAC3 is activated or mitophagy is inhibited.RESULTS785 compounds were characterized from Xinyin tablets, among which carbohydrates and glycosides, phenylpropanoids, terpenes were abundant, and a small number of amino acids, peptides and derivatives also existed in Xinyin tablets. In vivo, Xinyin tablets improved cardiac function (LVEF, LVFS, LVEDD, LVESD, and LVESV) and downregulated the expression of caspase-3, caspase-9, and Bax. The expression levels of PINK1 and Parkin subsequently increased. In vitro, the above findings were reinforced in H9c2 cardiomyocytes. Rapamycin and RGFP966 reduced the apoptosis of hypoxic H9C2 cardiomyocytes and increased mitophagy mediated by the HDAC3-mediated PINK1/Parkin signaling pathway.CONCLUSIONSXinyin tablets have potential as an intervention for CHF by improving mitophagy and inhibiting cardiomyocyte apoptosis through the HDAC3-mediated PINK1/Parkin signaling pathway.

01 Apr 2025·Journal of Pharmaceutical Sciences

Optimization of HPLC method for determination of Abraham solvation parameters of pharmaceuticals

Article

Author: Knašienė, Birutė ; Sadaunykas, Audrius ; Sazonovas, Andrius ; Balčiūnas, Simonas ; Naujalis, Evaldas ; Lanevskij, Kiril

Abraham solvation equation (Absolv) is a popular and well-established approach for modeling solute partitioning between phases of different polarity, which finds its applications in both organic chemistry and biomedical fields. Parameters constituting this equation are good quantitative descriptors of solute hydrogen bonding potential that are useful for QSAR modeling of more complex chemical and biological phenomena. Numerous studies dealing with fast determination of Abraham descriptors using HPLC can be found in the literature, but these mostly focus on small un-ionizable industrial and environmental chemicals, whereas experimental data for pharmaceutical molecules are clearly lacking. In the current study we build upon a previously published chromatographic approach, aiming to adapt the method to ionizable drug-like compounds, and optimize it by reducing the number of required HPLC columns. The analysis involves determination of the overall H-bond acidity (A), H-bond basicity (B) and polarity/polarizability (S) descriptors for 62 pharmaceutical molecules with previously unpublished parameter values.

01 Apr 2025·Drug Discovery Today

Ramipril, perindopril and trandolapril as potential chemosensitizers in ovarian cancer: Considerations for drug repurposing

Review

Author: Regulska, Katarzyna ; Kolenda, Tomasz ; Cybulski, Zefiryn ; Michalak, Marcin ; Stanisz, Beata J ; Kozłowska-Masłoń, Joanna ; Janiczek-Polewska, Marlena ; Gieremek, Paulina

Ovarian cancer (OC) has poor survival statistics and increasing prevalence. One of the new options for its therapy could be overcoming platinum resistance. In this review, we have considered the idea of repositioning angiotensin-converting enzyme inhibitors (ACE-Is) as chemosensitizers. These drugs have been shown to suppress angiogenesis and OC cell migration in preclinical studies. Moreover, clinical data have shown that using ACE-Is with standard chemotherapy prolongs patient survival. Based on this rationale, we discuss the available in vitro models of OC for future studies with ACE-Is and demonstrate an in silico approach that has enabled us to select the most promising molecules: perindopril, ramipril, trandolapril and their diketopiperazine derivatives.

News (Medical) associated with Perindopril Erbumine

11 Sep 2024

·www.drugs.com

Quadruple Single Pill Superior for Resistant Hypertension

WEDNESDAY, Sept. 11, 2024 -- For patients with resistant hypertension , a quadruple single pill is superior to triple therapy, according to a study presented at the European Society of Cardiology Congress, held from Aug. 30 to Sept. 2 in London. Stefano Taddei, from the University of Pisa in Italy, and colleagues conducted a double-blind, randomized trial involving patients with resistant hypertension. Participants completed an eight-week run-in period during which they received the triple combination of perindopril, indapamide, and amlodipine. Those with uncontrolled blood pressure (BP) after eight weeks while adherent to therapy were randomly allocated to continue the same triple therapy or receive a single-pill combination containing perindopril, indapamide, amlodipine, and bisoprolol. A total of 183 patients from 49 centers in 13 countries were included in the trial. The researchers found that the mean office sitting systolic BP was reduced by 20.67 and 11.32 mm Hg in the quadruple single-pill group and in the triple group, respectively, after eight weeks, with the adjusted difference significant in favor of the quadruple single pill. For the main secondary end point of mean 24-hour ambulatory systolic BP, there was a significant difference for the quadruple single pill versus the triple group (−7.53 mm Hg); in addition, there was a significant difference in favor of the quadruple single-pill group in mean office sitting diastolic BP (−6.14 mm Hg). BP control was achieved by 66.3 and 42.7 percent on the quadruple single pill and on triple therapy, respectively. "The availability of a quadruple single-pill combination that includes bisoprolol could help with non-adherence and provide much-needed effective BP control in patients with resistant or difficult-to-treat hypertension," Taddei said in a statement. Several authors disclosed ties to the pharmaceutical and medical device industry, including Servier, which funded the study. Press Release More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultClinical Study

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 Erbumine

External Link

KEGG	Wiki	ATC	Drug Bank
D00624	Perindopril Erbumine	C09AA04	DB00790

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Heart Diseases	Japan	Daiichi Sankyo Co., Ltd.	28 Sep 2005
Heart Failure	Netherlands	Servier Pharmaceuticals LLC	-
Heart Failure	South Korea	Servier Pharmaceuticals LLC	-
Heart Failure	Greece	Servier Pharmaceuticals LLC	-
Hypertension	South Korea	Servier Pharmaceuticals LLC	-

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Essential Hypertension	Discovery	United States	Symplmed Pharmaceuticals LLC	30 Dec 1993
Hypertension	Discovery	United States	Symplmed Pharmaceuticals LLC	30 Dec 1993

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISN WCN2024	Not Applicable	Diabetes Mellitus \| Kidney Failure, Chronic	155	Perindopril	lfxakjhsad(fjshbdszin) = kpxlrjzrcs yrqjrkaxlq (supxywnilv )	Positive	01 Apr 2024
ESH2022	Not Applicable	Diabetes Mellitus, Type 2	30	Canagliflozin 300 mg daily	(ryzyyaffgy) = avywdmczzi tmjfuqntgr (stunkdfdxm ) View more	Positive	01 Jun 2022
ESH2022	Not Applicable	Diabetes Mellitus, Type 2	30	Perindopril 10 mg daily	(ryzyyaffgy) = rjmyiqfvmr tmjfuqntgr (stunkdfdxm ) View more	Positive	01 Jun 2022
ESH2021	Not Applicable	Obesity \| Hypertension	-	Perindopril 10 mg + Indapamide 2.5 mg	aivtlrkgcf(uggmdbgqjt) = zismtaxfxw zkgklyiwws (xwilpnguuc, 26 - 75;34 to 25) View more	Positive	01 Apr 2021
ESH2021	Not Applicable	Diabetes Mellitus, Type 2 \| Hypertension serum uric acid	40	Canagliflozin 100-300 mg	(javyumpyol) = qhlqcnfjcl psdoxmtcmm (oirbvfpiwl ) View more	Positive	01 Apr 2021
ESH2021	Not Applicable	Diabetes Mellitus, Type 2 \| Hypertension serum uric acid	40	Perindopril 10 mg	yxvskmvkpa(kanbnvgtsy) = zieuurhslj xtfeyanojm (ektllpolug ) View more	Positive	01 Apr 2021
ESH2019	Not Applicable	Diabetes Mellitus, Type 2 metalloproteinase-9 (MMP-9) \| tissue inhibitor of metalloproteinase 1 (TIMP-1) \| E-selectin ... View more	30	Perindopril 10 mg/day	(jtpwjqryjh) = uiutzlglob pdfjaesaos (pchdpvkhmw ) View more	Positive	01 Jul 2019
NCT02651415 (Pubmed \| Cancer Chemother Pharmacol) Manual	Phase 2	Metastatic Colorectal Carcinoma	10	perindopril+regorafenib	nmwbjemgdx(cqzwvfytnk) = mipgdfzrte ntzybosfgk (evubfzacot )	Negative	01 Mar 2019
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)	lcnwuewrer(mbdmbsgfwo) = pzafyecxmm eykommhubs (zxjxipdiwk, ilqrwncipc - pvendasywp) View more	-	11 Dec 2017
NCT01669434 (CTgov)	Phase 4	Hypotension	291	ACEI continuation (ACEI Continuation)	lcnwuewrer(mbdmbsgfwo) = yvndolrwqn eykommhubs (zxjxipdiwk, jlyphyarjb - icfhfjaekm) View more	-	11 Dec 2017
ASCOT-LLA (ESC2017)	Not Applicable	Hypertension	3,876	AmPA (atorvastatin + perindopril + amlodipine)	(osiociblzx) = Fewer patients experienced at least one serious non non-fatal adverse event in the AmPA group than in the AmPP group (9.5% vs 10.3% respectively, p=0.006) bftarbtajn (iszpxmoyse ) View more	Positive	29 Aug 2017
ASCOT-LLA (ESC2017)	Not Applicable	Hypertension	3,876	AmPP (placebo + perindopril + amlodipine)		Positive	29 Aug 2017
ESC2017	Not Applicable	Hypertension	-	Perindopril+Atorvastatin	ejqpdvhjud(hydmgoagsu) = 4.5% of patients caqyylibbp (jqmrenmvvz ) View more	-	26 Aug 2017

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Perindopril Erbumine

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