特丁胺培哚普利/吲达帕胺/氨氯地平(Perindopril Erbumine/Indapamide/Amlodipine)

概要

基本信息

药物类型

小分子化药

别名

Perindopres Trio

靶点

ACE x VDCCs

作用方式

抑制剂、阻滞剂

作用机制

ACE抑制剂(血管紧张素转化酶抑制剂)、VDCCs阻滞剂(电压门控性钙通道复合体阻滞剂)、协同转运子抑制剂

治疗领域

心血管疾病

在研适应症-

非在研适应症

原发性高血压高血压

原研机构-

在研机构

Pharmtechnology, LLC

非在研机构

Institut de Recherches Intern Servier

Darnitsa Pharmaceutical Co.

权益机构-

最高研发阶段临床1期

首次获批日期-

最高研发阶段(中国)无进展

特殊审评-

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结构/序列

分子式C20H25ClN2O5

InChIKeyHTIQEAQVCYTUBX-UHFFFAOYSA-N

CAS号88150-42-9

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关联

4

项与特丁胺培哚普利/吲达帕胺/氨氯地平相关的临床试验

NCT07259733

/ RecruitingN/AIIT

Strategy for Rapid Control of Apparent Resistant Arterial Hypertension in the Public Health System (FAST Control)

This is a single-center, open-label, randomized clinical trial conducted at the Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. The study evaluates a simplified treatment strategy for patients with apparent resistant hypertension, comparing fixed triple combination therapy (perindopril, indapamide, and amlodipine) with usual care using multiple separate antihypertensive drugs. The primary objective is to compare 24-hour blood pressure control as measured by ABPM at 12 weeks between the two treatment strategies. Enrollment began on July 15, 2023, and this study was registered retrospectively.

开始日期2023-07-15

申办/合作机构

Instituto Dante Pazzanese de Cardiologia

[+1]

NCT05940909

/ Recruiting临床1期

Open-label Randomized Crossover Two Period Single Dose Bioequivalence Study of Two Formulations of Perindopril Erbumine/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg Tablets (Pharmtechnology LLC, Republic of Belarus) and Triplixam? 10 mg/2.5 mg/10 mg Tablets (Les Laboratoires Servier Industrie, France) in Healthy Volunteers Under Fasting Conditions

This is an open-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Triplixam?, 10 mg/2.5 mg/10 mg tablets) or the test (Perindopril Erbumine/ 8 mg/2.5 mg/10 mg Tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.

开始日期2023-06-24

申办/合作机构

Pharmtechnology, LLC

NCT05470764

/ Completed临床1期

Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover, Comparative, Oral Bioequivalence Study of Test Product PERINDOPRES® TRIO, 8 mg Perindopril Tert-Butylamine / 2.5 mg Indapamide/ 10 mg Amlodipine Tablets (PrJSC "Pharmaceutical Firm "Darnitsa") And Reference Product TRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg Perindopril Arginine / 2.5 mg Indapamide / 10 mg Amlodipine Film-Coated Tablets (Manufactured By Servier (Ireland) Industries Ltd) In Healthy, Adult Subjects Under Fasting Conditions

The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (PERINDOPRES® TRIO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide / 10 mg amlodipine tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and a Reference medication (marketed medicinal product TRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg perindopril arginine / 2.5 mg indapamide / 10 mg amlodipine film-coated tablets [manufactured by Servier (Ireland) Industries Ltd]) in healthy adult volunteers under fasting conditions.

开始日期2021-05-30

申办/合作机构

Darnitsa Pharmaceutical Co.

[+1]

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