[Translation] A randomized, open-label, single-dose, two-period, self-crossover bioequivalence study of perindopril indapamide tablets in healthy subjects under fasting and fed conditions

主要研究目的：以国药集团工业有限公司研制的培哚普利吲达帕胺片（规格：培哚普利叔丁胺盐4 mg，吲达帕胺1.25 mg）为受试制剂，按生物等效性研究的有关规定，与施维雅（天津）制药有限公司生产的培哚普利吲达帕胺片（参比制剂，商品名：百普乐®，规格：培哚普利叔丁胺盐4 mg，吲达帕胺1.25 mg）对比在健康人体内的相对生物利用度，考察两制剂的人体生物等效性。次要研究目的：观察培哚普利吲达帕胺片受试制剂和参比制剂（规格：培哚普利叔丁胺盐4 mg，吲达帕胺1.25 mg）在健康受试者中的安全性。

[Translation]

Main research purpose: Using the perindopril indapamide tablets (specifications: perindopril tert-butylamine salt 4 mg, indapamide 1.25 mg) developed by Sinopharm Group Industrial Co., Ltd. as the test preparation, according to the relevant provisions of bioequivalence studies, the relative bioavailability in healthy humans was compared with the perindopril indapamide tablets (reference preparation, trade name: Bipro®, specifications: perindopril tert-butylamine salt 4 mg, indapamide 1.25 mg) produced by Servier (Tianjin) Pharmaceutical Co., Ltd., to investigate the human bioequivalence of the two preparations. Secondary research purpose: Observe the safety of the test preparation and reference preparation of perindopril indapamide tablets (specifications: perindopril tert-butylamine salt 4 mg, indapamide 1.25 mg) in healthy subjects.

Start Date04 Aug 2023

Sponsor / Collaborator

China National Pharmaceutical Industry Corp. Ltd.

NCT05683301 / CompletedPhase 4IIT

Treatment Optimisation for Blood Pressure With Single-Pill Combinations in India

Hypertension is a leading cause of morbidity and mortality globally. Although multiple drugs are frequently used to treat it, in the South Asian context, evidence is lacking on best drug combinations. This trial aims to compare efficacy of three single-pill combinations of two anti-hypertensive agents on 24-hour ambulatory systolic blood pressure among 1968 individuals with hypertension. The trial is a single-blind randomized controlled trial spread across 37 hospitals in India.
Single Pill combinations (SPCs): 1) Amlodipine + Perindopril, 2) Perindopril + Indapamide, 3) Amlodipine + Indapamide

Start Date30 Aug 2022

Sponsor / Collaborator

Centre for Chronic Disease Control

[+2]

CTR20220865 / CompletedNot Applicable

培哚普利吲达帕胺片在中国健康受试者中进行的单中心、随机、开放、单次（空腹/餐后）、口服给药、两制剂、两序列、两周期、交叉的人体生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial), oral, two-formulation, two-sequence, two-period, crossover human bioequivalence study of perindopril indapamide tablets in healthy Chinese subjects

主要目的：观察中国健康受试者在空腹/餐后状态下单次口服受试制剂培哚普利吲达帕胺片（规格：4mg/1.25mg；生产企业：天津力生制药股份有限公司）和参比制剂培哚普利吲达帕胺片（商品名：百普乐；规格：4mg/1.25mg；持证商：施维雅（天津）制药有限公司，生产企业：施维雅（天津）制药有限公司）后的药代动力学特征，进行药代动力学关键参数的比较，评价空腹/餐后状态下两种制剂的生物等效性。次要目的：观察受试制剂培哚普利吲达帕胺片和参比制剂培哚普利吲达帕胺片（百普乐）在中国健康受试者的安全性。

[Translation]

Primary objective: To observe the pharmacokinetic characteristics of the test preparation Perindopril Indapamide Tablets (Specifications: 4mg/1.25mg; Manufacturer: Tianjin Lisheng Pharmaceutical Co., Ltd.) and the reference preparation Perindopril Indapamide Tablets (Trade name: Biprole; Specifications: 4mg/1.25mg; Licensee: Servier (Tianjin) Pharmaceutical Co., Ltd., Manufacturer: Servier (Tianjin) Pharmaceutical Co., Ltd.) in Chinese healthy subjects after a single oral administration in the fasting/postprandial state, to compare the key pharmacokinetic parameters, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary objective: To observe the safety of the test preparation Perindopril Indapamide Tablets and the reference preparation Perindopril Indapamide Tablets (Biprole) in Chinese healthy subjects.

Start Date18 May 2022

Sponsor / Collaborator

Tianjin Lisheng Pharmaceutical Co., Ltd.

100 Clinical Results associated with Perindopril/Indapamide

100 Translational Medicine associated with Perindopril/Indapamide

100 Patents (Medical) associated with Perindopril/Indapamide

168

Literatures (Medical) associated with Perindopril/Indapamide

01 Dec 2024·Diabetes, Obesity and Metabolism

Lipids and apolipoproteins and the risk of vascular disease and mortality outcomes in women and men with type 2 diabetes in the ADVANCE study

Article

Author: Hamet, Pavel ; Harrap, Stephen ; Mancia, Giuseppe ; Af Geijerstam, Peder ; Harris, Katie ; Woodward, Mark ; Chalmers, John ; Pikkemaat, Miriam ; Poulter, Neil ; Marre, Michel

AbstractAimWhether apolipoproteins (apolipoprotein A1, apolipoprotein B, apolipoprotein B/apolipoprotein A1 [ApoB/ApoA1] ratio) or very‐low‐density lipoprotein (VLDL) cholesterol are better risk predictors than established lipid risk markers, and whether there are sex differences, is uncertain, both in general populations and in patients with diabetes. The aim of this study was to assess the association between established risk markers, apolipoproteins and the risk of macro‐ and microvascular disease and death in a large study of women and men with diabetes and to assess the potential sex differences in the associations.Materials and MethodsEstablished lipid risk markers were studied in 11 140 individuals with type 2 diabetes from the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified‐Release Controlled Evaluation (ADVANCE) trial, and apolipoproteins (A1, B, ApoB/ApoA1 ratio) and VLDL cholesterol from nuclear magnetic resonance (NMR) lipid analyses in biobanked samples from 3586 individuals included in the ADVANCE case‐cohort study (ADVANCE CC). Primary outcomes were major macro‐ and microvascular events and death. Cox proportional hazards models adjusted for confounders were used to quantify the associations (hazard ratio [HR] and 95% confidence intervals [CIs]) between established lipid risk markers and apolipoproteins with study outcomes. To address potential effect modification by sex, we investigated the association between the lipid risk markers and outcomes in subgroup analyses by sex.ResultsThere was a lower risk of macrovascular complications for high‐density lipoprotein (HDL) cholesterol (HR [95%CI] 0.88 [0.82–0.95]), a higher risk for total cholesterol (1.10 [1.04–1.17]), low‐density lipoprotein (LDL) cholesterol (1.15 [1.08–1.22]), non‐HDL cholesterol (1.13 [1.07–1.20]) and the total cholesterol/HDL ratio (1.20 [1.14–1.27]) but no significant associations with triglycerides from ADVANCE. There was a higher risk of macrovascular complications for the ApoB/ApoA1 ratio (1.13 [1.03–1.24]) from the ADVANCE CC. Only the ApoB/ApoA1 ratio (1.19 [1.06–1.34]), but none of the established lipid risk markers, was associated with a higher risk of microvascular complications. There were no statistically significant sex differences for any of the established lipid risk markers or apolipoproteins with any outcome. Using C‐statistics and net reclassification improvement (NRI) did not detect significant improvement in predicting all outcomes by adding lipids or apolipoproteins to the models with confounding factors only.Conclusions/InterpretationAll established lipid risk markers, except triglycerides, were predictors of macrovascular complications, but not microvascular complications, in patients with type 2 diabetes. The ApoB/ApoA1 ratio was associated with major macro‐ and microvascular complications, but there was no evidence that apolipoproteins are better than established lipid risk markers in predicting cardiovascular complications in patients with type 2 diabetes.

01 Dec 2024·Journal of Hypertension

Combination blood pressure lowering therapy in patients with type 2 diabetes: messages from the ADVANCE trial

Review

Author: Harrap, Stephen ; Chalmers, John ; Poulter, Neil ; Mancia, Giuseppe ; Wang, Nelson ; Harris, Katie ; Woodward, Mark ; Marre, Michel ; Hamet, Pavel ; Grobbee, Diederick E.

The Action in Diabetes and Vascular disease: preterAx and diamicroN Controlled Evaluation (ADVANCE) trial investigated the effects of intensive blood pressure (BP) lowering using a fixed combination of perindopril-indapamide versus placebo in type 2 diabetes (T2D). The study showed that combination perindopril-indapamide had significant benefits in reducing cardiovascular, renal, and mortality events, with consistent relative risk reductions across different patient subgroups. Secondary analyses of ADVANCE have identified novel risk markers in T2D including cessation of BP lowering therapy, absent peripheral pulses and cardiac biomarkers to name a few. ADVANCE also shed light on practical aspects of hypertension management, including the limitations of office BP, tolerability of combination BP lowering therapy across the range of BP levels and the interpretation of changes in serum creatinine after treatment initiation. This review article summarizes the findings of ADVANCE and its subsequent substudies, which have been foundational in our understanding of BP management and the use of combination BP lowering therapy in T2D.

01 May 2024·Diabetes Care

Haptoglobin Phenotype and Intensive Glycemic Control for Coronary Artery Disease Risk Reduction in People With Type 2 Diabetes: The ADVANCE Study

Article

Author: Poulter, Neil ; Cahill, Leah E ; Rimm, Eric B ; Samuel, Michelle ; Warren, Rachel A ; Selvin, Elizabeth ; Marre, Michel ; Mancia, Giuseppe ; Woodward, Mark ; Chalmers, John ; Levy, Andrew P ; Harris, Katie ; Carew, Allie S ; Lavallée, Samantha K ; Sapp, John ; Harrap, Stephen

OBJECTIVEIntensive glycemic control reduced coronary artery disease (CAD) events among the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study participants with the haptoglobin (Hp)2-2 phenotype but not in participants without the Hp2-2 phenotype. It is unknown whether and how these results translate across different demographic/clinical characteristics and treatment strategies.RESEARCH DESIGN AND METHODSHaptoglobin phenotype was measured in available samples from the Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) biomarker case-cohort study. Weighted multivariable-adjusted Cox regression models were used to evaluate the association between intensive glycemic control (HbA1c target of ≤6.5%) versus standard therapy (based on local guidelines) and major CAD events among participants with (n = 1,327) and without (n = 2,077) the Hp2-2 phenotype separately and within prespecified stratifications by sex, race, previous cardiovascular disease (CVD), diabetes duration, and HDL-cholesterol.RESULTSWhile the hazard ratios (HRs) were in the hypothesized differing directions, compared with standard therapy, intensive glycemic control was not significantly associated with risk of CAD events among participants without (1.04, 95% CI 0.82–1.32) or with (0.84, 0.63–1.14, Pinteraction = 0.27) the Hp2-2 phenotype overall. Intensive therapy was associated with lower CAD risk among participants with the Hp2-2 phenotype who had no previous CVD (0.47, 0.29–0.76, Pinteraction = 0.01).CONCLUSIONSOur findings suggest that intensive glycemic control contributes to the prevention of major CAD events among ADVANCE participants with the Hp2-2 phenotype and no previous CVD and are in alignment with our hypothesis that intensive glycemic control may be beneficial in a subset of people with the Hp2-2 phenotype.

News (Medical) associated with Perindopril/Indapamide

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/Indapamide

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	C09BA04	-

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hypertension	CN	Servier Tianjin Pharmaceutical Co. Ltd.	07 Sep 2005

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ADVANCE (ASN2015)	Not Applicable	Diabetes Mellitus \| Vascular Diseases UACR	9,195	PreterAx	(khzzjrouxg): HR = 0.1 (95% CI, 0.01 - 0.79)	Positive	03 Nov 2015
				PreterAx
NCT00145925 (ADVANCE, Pubmed \| Dan Med J)	Phase 3	Diabetes Mellitus, Type 2	11,140	Preterax (Normal cognitive function)	dsykedxhld(vjawxmjbgm): HR = 1.33 (95% CI, 1.16 - 1.54), P-Value = < 0.03 View more	-	01 Nov 2009
				Preterax (Mild cognitive dysfunction)

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