Delving into the Latest Updates on Amlodipine Besylate/Atorvastatin Calcium with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Amlodipine Besilate/Atorvastatin Calcium Hydrate, Amlodipine Besylate/Atorvastatin Calcium Hydrate, Amlodipine/atorvastatin

+ [6]

Target

HMG-CoA reductase x VDCCs

Mechanism

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

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesCongenital Disorders+ [2]

Active Indication

Hyperlipoproteinemia Type IIAngina PectorisCoronary Disease+ [11]

Inactive Indication-

Originator Organization

Pfizer Inc.

Active Organization

Pfizer Inc.Viatris Pharmaceuticals Co., Ltd.Pharmacia & Upjohn, Inc.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (30 Jan 2004),

Angina Pectoris, VariantAngina, StableDyslipidemias+ [6]

Regulation-

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Structure

Molecular FormulaC33H35CaFN2O5

InChIKeyBWFCZHDTTAYGNN-CNZCJKERSA-N

CAS Registry134523-03-8

View All Structures (2)

按有关生物等效性试验的规定，选择Pharmacia and Upjohn Co LLC为持证商的氨氯地平阿托伐他汀钙片（商品名：Caduet®，规格：5mg/10mg（以氨氯地平/阿托伐他汀计））为参比制剂，对翎耀生物科技（上海）有限公司提供的受试制剂氨氯地平阿托伐他汀钙片（规格：5mg/10mg（以氨氯地平/阿托伐他汀计））进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹和餐后给药条件下的生物等效性。

[Translation]

In accordance with the relevant provisions of bioequivalence tests, amlodipine atorvastatin calcium tablets (trade name: Caduet®, specification: 5mg/10mg (calculated as amlodipine/atorvastatin)) with Pharmacia and Upjohn Co LLC as the licensee were selected as the reference preparation, and the test preparation amlodipine atorvastatin calcium tablets (specification: 5mg/10mg (calculated as amlodipine/atorvastatin)) provided by Lingyao Biotechnology (Shanghai) Co., Ltd. were subjected to human bioequivalence tests on fasting and fed administration to compare whether the absorption rate and degree of the drug in the test preparation were within an acceptable range with those of the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and fed administration conditions.

Start Date20 May 2024

Sponsor / Collaborator

Lingyao Biotechnology (Shanghai) Co., Ltd.

CTR20233897 / CompletedNot Applicable

氨氯地平阿托伐他汀钙片在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、三序列、三周期、部分重复交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, three-sequence, three-period, partially repeated crossover bioequivalence study of amlodipine and atorvastatin calcium tablets in Chinese healthy volunteers under fasting and fed conditions

主要研究目的：按有关生物等效性试验的规定，选择Pharmacia and Upjohn Co LLC为持证商的氨氯地平阿托伐他汀钙片（商品名：Caduet®，规格：5mg/10mg（以氨氯地平/阿托伐他汀计））为参比制剂，对宁波大红鹰药业股份有限公司提供的受试制剂氨氯地平阿托伐他汀钙片（规格：5mg/10mg（以氨氯地平/阿托伐他汀计））进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂氨氯地平阿托伐他汀钙片（规格：5mg/10mg（以氨氯地平/阿托伐他汀计））和参比制剂氨氯地平阿托伐他汀钙片（商品名：Caduet®，规格：5mg/10mg（以氨氯地平/阿托伐他汀计））的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, the amlodipine atorvastatin calcium tablets (trade name: Caduet®, specification: 5mg/10mg (amlodipine/atorvastatin)) of Pharmacia and Upjohn Co LLC as the licensee were selected as the reference preparation, and the test preparation amlodipine atorvastatin calcium tablets (specification: 5mg/10mg (amlodipine/atorvastatin)) provided by Ningbo Dahongying Pharmaceutical Co., Ltd. were subjected to fasting and postprandial human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary study objective: To observe the safety of oral administration of the test preparation amlodipine atorvastatin calcium tablets (specification: 5mg/10mg (calculated as amlodipine/atorvastatin)) and the reference preparation amlodipine atorvastatin calcium tablets (trade name: Caduet®, specification: 5mg/10mg (calculated as amlodipine/atorvastatin)) in healthy volunteers.

Start Date22 Dec 2023

Sponsor / Collaborator

Ningbo Dahongying Pharmaceutical Co. Ltd.

CTR20231343 / CompletedNot Applicable

氨氯地平阿托伐他汀钙片单中心、随机、开放、单剂量、两制剂、三周期、部分重复交叉健康人体餐后条件下生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, three-period, partially repeated crossover bioequivalence study of amlodipine and atorvastatin calcium tablets in healthy volunteers under postprandial conditions

主要研究目的观察中国健康受试者餐后条件下口服受试制剂氨氯地平阿托伐他汀钙片（规格：5mg /10mg，北京双鹭药业股份有限公司生产）与参比制剂氨氯地平阿托伐他汀钙片（商品名：多达一®，规格：5mg /10mg；Pfizer Manufacturing Deutschland GmbH(Betriebsstatte Freibrug)生产）的药代动力学特点，评价两制剂的人体生物等效性。次要研究目的观察受试制剂氨氯地平阿托伐他汀钙片和参比制剂多达一®在健康成年受试者中的安全性。

[Translation]

Main study objectives To observe the pharmacokinetic characteristics of the test preparation amlodipine atorvastatin calcium tablets (specification: 5mg/10mg, produced by Beijing Shuanglu Pharmaceutical Co., Ltd.) and the reference preparation amlodipine atorvastatin calcium tablets (trade name: Up to 1®, specification: 5mg/10mg; produced by Pfizer Manufacturing Deutschland GmbH (Betriebsstatte Freibrug)) taken orally in healthy Chinese subjects after meals, and to evaluate the bioequivalence of the two preparations in humans. Secondary study objectives To observe the safety of the test preparation amlodipine atorvastatin calcium tablets and the reference preparation Up to 1® in healthy adult subjects.

Start Date06 Jul 2023

Sponsor / Collaborator

Beijing SL Pharmaceutical Co., Ltd.

100 Clinical Results associated with Amlodipine Besylate/Atorvastatin Calcium

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100 Translational Medicine associated with Amlodipine Besylate/Atorvastatin Calcium

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100 Patents (Medical) associated with Amlodipine Besylate/Atorvastatin Calcium

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15

Literatures (Medical) associated with Amlodipine Besylate/Atorvastatin Calcium

01 Dec 2014·BMC ophthalmologyQ4 · MEDICINE

Chronic unilateral chemosis following the use of amlodipine besylate

Q4 · MEDICINE

ArticleOA

Author: Wan Soo Kim ; Kyeong Hwan Kim

BACKGROUND:

This case report describes a patient with chronic unilateral chemosis, likely due to treatment with amlodipine besylate.

CASE PRESENTATION:

A 52-year-old man visited the clinic with symptoms of foreign body sensation and puffiness in his right eye, which had persisted for 4 months. There were no other symptoms, such as itching and pain, in his right eye and no specific symptoms in his left eye. He had been treated for hypertension and hyperlipidemia for the previous 5 months with once daily amlodipine besylate/atorvastatin (Caduet) and candesartan cilexetil (Atacand). Examination revealed marked swelling of the inferior bulbar conjunctiva in the right eye. Evaluation revealed no specific causes for the longstanding chemosis. A change of medication to telmisartan/hydrochlorothiazide (Micardis Plus) without amlodipine besylate resulted in significant improvements in his symptoms after 1 month and complete remission after 8 months.

CONCLUSION:

Prior to invasive evaluation including biopsy, specific drugs should be considered as possible causes of idiopathic longstanding conjunctival chemosis.

01 Jan 2013·Analytical chemistry insights

Simultaneous Determination of Amlodipine Besylate and Atorvastatin Calcium in Binary Mixture by Spectrofluorimetry and HPLC Coupled with Fluorescence Detection

Article

Author: Ahmed, Maha S. ; Mahrouse, Marianne A. ; Moussa, Bahia A. ; El-Zaher, Asmaa A.

Caduet tablets are novel prescription drug that combines amlodipine besylate (AM) with atorvastatin calcium (AT). A spectrofluorimetric and an HPLC-fluorescence detection methods were developed for simultaneous determination of both drugs in tablets. In the spectrofluorimetric method, native fluorescence of AM and AT were measured in methanol at 442 and 369 nm upon excitation at 361 and 274 nm, respectively. The emission spectrum of each drug reveals zero value at the emission wavelength of the other drug, thus allowing their simultaneous determination without interference. In the HPLC method, separation of AM and AT was achieved within 8 minutes on a C18column using acetonitrile:phosphate buffer (0.015 M, pH 3) (45:55, v/v) as the mobile phase. Fluorescence detection was carried out using excitation wavelengths 361 and 274 nm and emission wavelengths 442 and 378 nm for AM and AT, respectively. Excellent linearity was observed. Careful validation proved advantages of the new methods: high sensitivity, accuracy, selectivity and suitability for quality control laboratories.

01 Jan 2013·Advances in therapyQ3 · MEDICINE

Slovak Trial on Cardiovascular Risk Reduction Following National Guidelines with CaDUET® (The STRONG DUET Study)

Q3 · MEDICINE

Article

Author: Jan Fedacko ; Lucia Merkovska ; Peter Jarcuska ; Martin Janicko ; Matej Sajty ; Tomas Lopuchovsky ; Lucia Jedlickova ; Daniel Pella ; Jan Kmec ; Frantisek Sabol

INTRODUCTION:

The efficacy and safety of single-pill amlodipine/atorvastatin for reducing blood pressure (BP), low-density lipoprotein cholesterol (LDLC), and predicted 10-year cardiovascular (CV) risk have been demonstrated in low CV risk countries. The Slovak Trial on Cardiovascular Risk Reduction Following National Guidelines with CaDUET® (amlodipine besylate/atorvastatin calcium; Pfizer, Morrisville, PA, USA; STRONG DUET) study evaluated its clinical utility in Slovakia, one of the highest CV risk regions in Europe.

METHODS:

This was a two-phase study involving 100 outpatient cardiologist and internist departments in Slovakia. Phase 1 assessed BP control and CV risk profiles in adults with treated hypertension, and phase 2 was an open-label, multicenter, observational study. In the phase 2 study, patients with treated but uncontrolled hypertension and three or more coronary heart disease risk factors received single-pill amlodipine/atorvastatin (5/10 or 10/10 mg) for 12 weeks. Major outcomes were the percentage of patients achieving target BP (≤140/90 mmHg) and/or LDL-C (≤3 mmol/L) and reductions in predicted 10-year CV risk.

RESULTS:

Of the 4,672 phase 1 patients, 80.8% had uncontrolled hypertension and 61.4% had dyslipidemia. Of the 1,406 phase 2 patients, 90.3% of patients achieved target BP at week 12, 66.3% achieved target LDL-C, and 60.7% achieved both. The mean 10-year CV risk was reduced by 49% (P < 0.0001); treatment was well-tolerated and safe.

CONCLUSION:

Single-pill amlodipine/atorvastatin was associated with significant improvements in BP, LDL-C target attainment, and 10-year CV risk in patients with uncontrolled hypertension in Slovakia. The treatment was well-tolerated and safe. Use of single-pill amlodipine/atorvastatin in high CV-risk countries could lead to significant improvements in CV risk management.

100 Deals associated with Amlodipine Besylate/Atorvastatin Calcium

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Amlodipine Besylate/Atorvastatin Calcium	C10BX03	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hyperlipoproteinemia Type II	JP	Viatris Pharmaceuticals Co., Ltd.	07 Jul 2009
Angina Pectoris	CN	Pfizer Inc.	03 Apr 2008
Coronary Disease	CN	Pfizer Inc.	03 Apr 2008
Hyperlipidemias	CN	Pfizer Inc.	03 Apr 2008
Hypercholesterolemia	CN	Pfizer Inc.	19 Apr 2005
Angina Pectoris, Variant	US	Pharmacia & Upjohn, Inc.	30 Jan 2004
Angina, Stable	US	Pharmacia & Upjohn, Inc.	30 Jan 2004
Dyslipidemias	US	Pharmacia & Upjohn, Inc.	30 Jan 2004
Heterozygous familial hypercholesterolemia	US	Pharmacia & Upjohn, Inc.	30 Jan 2004
HoFM	US	Pharmacia & Upjohn, Inc.	30 Jan 2004
Hyperlipoproteinemia Type III	US	Pharmacia & Upjohn, Inc.	30 Jan 2004
Hypertension	US	Pharmacia & Upjohn, Inc.	30 Jan 2004
Hypertriglyceridemia	US	Pharmacia & Upjohn, Inc.	30 Jan 2004
Primary hypercholesterolemia	US	Pharmacia & Upjohn, Inc.	30 Jan 2004

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01190007 (CTgov)	Phase 4	Angina Pectoris \| Hypertension \| Hypercholesterolemia	159	Caduet	drnwptfyqv(vmrgqmdbxa) = uquevrysdb jzrtsmwsza (vmlgaycvle, fvumzrkzau - bdrbaxulnk) View more	-	03 Dec 2012
NCT00407537 (CRUCIAL, CTgov)	Phase 4	Hypertension \| Hypercholesterolemia	1,531	Amlodipine besylate/atorvastatin calcium single pill combination	mdspufgiwq(cnmgxxokop) = uqqhqveoib eorbhfsobt (ouvsxrfudt, gfmgtomohe - jzuexajifa) View more	-	11 Nov 2011
NCT00412113 (TOGETHER, CTgov)	Phase 4	Dyslipidemias \| Hypertension	245	placebo+Caduet (Norvasc + TLC)	iaamdqvjnn(cirhnodbkp) = seoxonryrl pzrcnycygm (wngesnszed, csxskeezzg - hsakkofjbr) View more	-	06 Nov 2009
NCT00412113 (TOGETHER, CTgov)	Phase 4	Dyslipidemias \| Hypertension	245	Norvasc placebo+atorvastatin calcium+TLC+amlodipine besylate (Caduet + TLC)	iaamdqvjnn(cirhnodbkp) = fjbkszmdwr pzrcnycygm (wngesnszed, jbficemran - gtbjdczvhe) View more	-	06 Nov 2009
NCT00174304 \| NCT00330785 (JEWEL programme, Pubmed)	Not Applicable	Dyslipidemias \| Hyperlipidemias \| Hypertension	2,245	Single-pill amlodipine/atorvastatin	skkeuceuoa(iqxwivmhgj) = goopnlemud ndaefytxwn (fplfemeukp )	-	01 Aug 2009
NCT00530946 (CTgov)	Phase 3	Hyper LDL cholesterolaemia \| Hypertension	165	CI-1038 (CI-1038 2.5 mg/5 mg)	xbgtpolsdb(cubnapqlky) = pbrodkqdsj vibzgqxzzf (akyooqnbit, hgpvtlmjvr - vtzsqdjlul) View more	-	13 Apr 2009
NCT00530946 (CTgov)	Phase 3	Hyper LDL cholesterolaemia \| Hypertension	165	CI-1038 (CI-1038 2.5 mg/10 mg)	xbgtpolsdb(cubnapqlky) = bojzlodfch vibzgqxzzf (akyooqnbit, bjcgnqcaem - pgawtjwukg) View more	-	13 Apr 2009