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

HMGCR x VDCCs

Action

inhibitors, blockers

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

Hyper LDL cholesterolaemia

Originator Organization

Pfizer Inc.

Active Organization

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

Pfizer Inc.

Inactive Organization

Viatris, Inc.

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (30 Jan 2004),

Angina Pectoris, VariantAngina, StableDyslipidemias+ [6]

Regulation-

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Structure/Sequence

Molecular FormulaC26H31ClN2O8S

InChIKeyZPBWCRDSRKPIDG-UHFFFAOYSA-N

CAS Registry111470-99-6

View All Structures (3)

主要目的：考察空腹/餐后单次口服受试制剂氨氯地平阿托伐他汀钙片（规格：5 mg/20 mg（以氨氯地平/阿托伐他汀计），安徽佳和药业有限公司生产）与参比制剂氨氯地平阿托伐他汀钙片（多达一®，规格：5 mg/20 mg（以氨氯地平/阿托伐他汀计），Pfizer Manufacturing Deutschland GmbH生产），在中国成年健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性。次要目的：评价空腹/餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。

[Translation]

Main purpose: To investigate the relative bioavailability of the test preparation amlodipine atorvastatin calcium tablets (specifications: 5 mg/20 mg (in terms of amlodipine/atorvastatin), produced by Anhui Jiahe Pharmaceutical Co., Ltd.) and the reference preparation amlodipine atorvastatin calcium tablets (DaDaYi®, specifications: 5 mg/20 mg (in terms of amlodipine/atorvastatin), produced by Pfizer Manufacturing Deutschland GmbH) in healthy Chinese adults after a single oral administration on an empty stomach/after a meal, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations. Secondary purpose: To evaluate the safety of the test preparation and the reference preparation in healthy Chinese adults after a single oral administration on an empty stomach/after a meal.

Start Date25 Oct 2024

Sponsor / Collaborator

Anhui Jiahe Pharmaceutical Co., Ltd.

CTR20243396

/ CompletedNot Applicable

健康受试者空腹和餐后单次口服氨氯地平阿托伐他汀钙片的随机、开放、单剂量、两制剂、两序列、四周期、完全重复交叉设计生物等效性试验。

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, four-period, completely repeated crossover design bioequivalence study of a single oral dose of amlodipine and atorvastatin calcium tablets in healthy subjects on an empty stomach or after a meal.

主要目的：研究空腹和餐后状态下单次口服受试制剂氨氯地平阿托伐他汀钙片（规格：5mg /10mg，安徽肽渡生物医药科技有限公司持证，裕松源药业有限公司生产）与参比制剂氨氯地平阿托伐他汀钙片（多达一®，规格：5mg/10mg，Pfizer Manufacturing Deutschland GmbH生产）在健康成年受试者体内的药代动力学，评价空腹和餐后状态口服两种制剂的生物等效性。次要目的：空腹和餐后状态下，研究单次口服受试制剂氨氯地平阿托伐他汀钙片和参比制剂氨氯地平阿托伐他汀钙片（多达一®）在健康成年受试者中的安全性。

[Translation]

Primary objective: To study the pharmacokinetics of the test preparation amlodipine atorvastatin calcium tablets (specifications: 5mg/10mg, licensed by Anhui Peptide Biotechnology Co., Ltd., produced by Yusongyuan Pharmaceutical Co., Ltd.) and the reference preparation amlodipine atorvastatin calcium tablets (Up to One®, specifications: 5mg/10mg, produced by Pfizer Manufacturing Deutschland GmbH) in healthy adult subjects in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary objective: To study the safety of the test preparation amlodipine atorvastatin calcium tablets and the reference preparation amlodipine atorvastatin calcium tablets (Up to One®) in healthy adult subjects in the fasting and fed state.

Start Date05 Oct 2024

Sponsor / Collaborator

An Hui Tai Du Sheng Wu Yi Yao Ke Ji You Xian Gong Si

CTR20241265

/ 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

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.

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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17

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: Kyeong Hwan Kim ; Wan Soo Kim

BACKGROUNDThis case report describes a patient with chronic unilateral chemosis, likely due to treatment with amlodipine besylate.CASE PRESENTATIONA 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.CONCLUSIONPrior 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: El-Zaher, Asmaa A. ; Moussa, Bahia A. ; Ahmed, Maha S. ; Mahrouse, Marianne 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: Peter Jarcuska ; Tomas Lopuchovsky ; Frantisek Sabol ; Daniel Pella ; Jan Fedacko ; Jan Kmec ; Lucia Merkovska ; Matej Sajty ; Martin Janicko ; Lucia Jedlickova

INTRODUCTIONThe 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.METHODSThis 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.RESULTSOf 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.CONCLUSIONSingle-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

Approved

10 top approved records.

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypertension	Discovery	Hong Kong	Viatris, Inc.	01 May 2004
Hypertension	Discovery	Jordan	Viatris, Inc.	01 May 2004
Hypertension	Discovery	Australia	Viatris, Inc.	01 May 2004
Hypertension	Discovery	Turkey	Viatris, Inc.	01 May 2004
Hypertension	Discovery	Mexico	Viatris, Inc.	01 May 2004
Hypertension	Discovery	Saudi Arabia	Viatris, Inc.	01 May 2004
Hypertension	Discovery	Tunisia	Viatris, Inc.	01 May 2004
Hypertension	Discovery	United Arab Emirates	Viatris, Inc.	01 May 2004
Hypertension	Discovery	India	Viatris, Inc.	01 May 2004
Hypertension	Discovery	Israel	Viatris, Inc.	01 May 2004

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASN2014	Not Applicable	Chronic Kidney Diseases	-	Amlodipine/Atorvastatin 2.5/5 mg	(iequmqzhhl) = eunbtoauru fzimkaqvkx (lihtbsesrc ) View more	Positive	11 Nov 2014
				Amlodipine/Atorvastatin 2.5/10 mg	(iequmqzhhl) = nprkdnihdj fzimkaqvkx (lihtbsesrc ) View more
NCT01190007 (CTgov)	Phase 4	Angina Pectoris \| Hypertension \| Hypercholesterolemia	159	Caduet	(eikdkmburp) = cnidemlgbr eqnmvuxakm (brofovsmbz, qlwtvhauuu - ntetkizpeo) View more	-	03 Dec 2012
NCT00407537 (CRUCIAL, CTgov)	Phase 4	Hypertension \| Hypercholesterolemia	1,531	Amlodipine besylate/atorvastatin calcium single pill combination	wctqebvhmh(tksvmoczpw) = mpvfmjlcfn tjmukvadbm (bmugxvmhsl, xfhotcgrch - sqizdwobvc) View more	-	11 Nov 2011
NCT00412113 (TOGETHER, CTgov)	Phase 4	Dyslipidemias \| Hypertension	245	placebo+Caduet (Norvasc + TLC)	aqexvrezsr(vmdaqzlzpk) = fsybgumdbp uutugazuhg (fotjpacedq, jlerefrqxm - dgnyjkstch) View more	-	06 Nov 2009
				Norvasc placebo+atorvastatin calcium+TLC+amlodipine besylate (Caduet + TLC)	aqexvrezsr(vmdaqzlzpk) = yurngrmqqg uutugazuhg (fotjpacedq, jrchrthraa - xbyuujznlv) View more
NCT00530946 (CTgov)	Phase 3	Hyper LDL cholesterolaemia \| Hypertension	165	CI-1038 (CI-1038 2.5 mg/5 mg)	wsixmqtnkm(uqcdcgyujw) = gqhyrrzzdu sdqgeaqkoy (pcgregtxri, rjnlrbqesb - dsfsswacrw) View more	-	13 Apr 2009
				CI-1038 (CI-1038 2.5 mg/10 mg)	wsixmqtnkm(uqcdcgyujw) = iuarrwlfrv sdqgeaqkoy (pcgregtxri, reeuygftxp - jqdcfxovcp) View more