Delving into the Latest Updates on Atorvastatin Calcium Hydrate/Levamlodipine MaleateMaleate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms-

Target

HMG-CoA reductase x L-type calcium channel

Mechanism

HMG-CoA reductase inhibitors(HMG-CoA reductase inhibitors), L-type calcium channel blockers(Voltage-gated L-type calcium channel blockers)

Therapeutic Areas

Cardiovascular DiseasesEndocrinology and Metabolic Disease

Active Indication

HyperlipidemiasHypertension

Inactive Indication-

Originator Organization

CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.

Active Organization

CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.

CSPC Ouyi Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC33H35CaFN2O5

InChIKeyBWFCZHDTTAYGNN-CNZCJKERSA-N

CAS Registry134523-03-8

View All Structures (3)

主要目的：研究空腹状态下单次口服受试制剂苯磺酸左旋氨氯地平阿托伐他汀钙片（规格：2.5mg:10mg（以左旋氨氯地平/阿托伐他汀计），北京红太阳药业有限公司生产）与参比制剂苯磺酸氨氯地平片（商品名：络活喜，规格：5mg/片；辉瑞制药有限公司生产）及阿托伐他汀钙片（商品名：立普妥，规格：10mg/片；Pfizer Inc.生产）在健康成年受试者体内的药代动力学，评价空腹状态口服两种制剂的生物等效性。次要目的：研究受试制剂苯磺酸左旋氨氯地平阿托伐他汀钙片和参比制剂苯磺酸氨氯地平片（络活喜）及阿托伐他汀钙片（立普妥）在健康成年受试者中的安全性。

[Translation]

Primary objective: To study the pharmacokinetics of a single oral dose of the test preparation levamlodipine besylate atorvastatin calcium tablets (specification: 2.5mg:10mg (calculated as levamlodipine/atorvastatin), produced by Beijing Red Sun Pharmaceutical Co., Ltd.) and the reference preparations amlodipine besylate tablets (trade name: Norvasc, specification: 5mg/tablet; produced by Pfizer Pharmaceutical Co., Ltd.) and atorvastatin calcium tablets (trade name: Lipitor, specification: 10mg/tablet; produced by Pfizer Inc.) in healthy adult subjects in the fasting state, and to evaluate the bioequivalence of the two preparations when taken orally in the fasting state. Secondary objective: To study the safety of the test preparation levamlodipine besylate atorvastatin calcium tablets and the reference preparations amlodipine besylate tablets (Norvasc) and atorvastatin calcium tablets (Lipitor) in healthy adult subjects.

Start Date14 Aug 2020

Sponsor / Collaborator

Beijing Red Sun Pharmaceutical Co. Ltd.

CTR20150372

/ RecruitingPhase 2

马来酸左旋氨氯地平/阿托伐他汀钙复方片治疗高血压高血脂的多中心、双盲双模拟、随机、平行对照临床研究

[Translation] A multicenter, double-blind, double-dummy, randomized, parallel controlled clinical study on the treatment of hypertension and hyperlipidemia using levamlodipine maleate/atorvastatin calcium compound tablets

以马来酸左旋氨氯地平片及阿托伐他汀钙片单药为对照，评价马来酸左旋氨氯地平/阿托伐他汀钙复方片（AM/AT片）马来酸左旋氨氯地平片与阿托伐他汀钙片之间有无药效学的相互影响，并关注该药初步的安全性和有效性，为药品后续的研究提供支持。

[Translation]

Using levamlodipine maleate tablets and atorvastatin calcium tablets as controls, this study evaluated whether there were any pharmacodynamic interactions between levamlodipine maleate/atorvastatin calcium combination tablets (AM/AT tablets), levamlodipine maleate tablets and atorvastatin calcium tablets, and focused on the initial safety and efficacy of the drug to provide support for subsequent research on the drug.

Start Date12 Oct 2015

Sponsor / Collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

[+1]

CTR20130727

/ RecruitingNot Applicable

马来酸左旋氨氯地平/阿托伐他汀钙片人体生物利用度生物等效性及药代动力学对比性研究

[Translation] Comparative study on bioavailability, bioequivalence and pharmacokinetics of levamlodipine maleate/atorvastatin calcium tablets in healthy volunteers

通过马来酸左旋氨氯地平/阿托伐他汀钙片AM/AT（T）与玄宁AM（参比制剂R1）和立普妥AT（R）联合使用药代参数比较，评价AM/AT与AM和AT联合使用时是否生物等效性；通过AMAT与多达一药代参数比较，评价AMAT的药代动力学特征。为该药临床应用的有效性和安全性提供依据。

[Translation]

By comparing the pharmacokinetic parameters of levamlodipine maleate/atorvastatin calcium tablets AM/AT (T) with Xuanning AM (reference preparation R1) and Lipitor AT (R), we evaluated whether AM/AT is bioequivalent to the combination of AM and AT; by comparing AMAT with up to one pharmacokinetic parameter, we evaluated the pharmacokinetic characteristics of AMAT, providing a basis for the effectiveness and safety of the drug in clinical application.

Start Date07 Jul 2014

Sponsor / Collaborator

CSPC Ouyi Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Atorvastatin Calcium Hydrate/Levamlodipine MaleateMaleate

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100 Translational Medicine associated with Atorvastatin Calcium Hydrate/Levamlodipine MaleateMaleate

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100 Patents (Medical) associated with Atorvastatin Calcium Hydrate/Levamlodipine MaleateMaleate

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100 Deals associated with Atorvastatin Calcium Hydrate/Levamlodipine MaleateMaleate

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperlipidemias	Phase 2	CN	CSPC Ouyi Pharmaceutical Co., Ltd.	12 Oct 2015
Hyperlipidemias	Phase 2	CN	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	12 Oct 2015
Hypertension	Phase 2	CN	CSPC Ouyi Pharmaceutical Co., Ltd.	12 Oct 2015
Hypertension	Phase 2	CN	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	12 Oct 2015