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

主要研究目的：研究空腹和餐后状态下单次口服受试制剂缬沙坦氨氯地平片（Ⅰ）（规格：每片含缬沙坦80mg，氨氯地平5mg，苏州俞氏药业有限公司生产）与参比制剂缬沙坦氨氯地平片（Ⅰ）（倍博特®，规格：每片含缬沙坦80mg，氨氯地平5mg，Siegfried Barbera S.L.生产, Novartis Pharma Schweiz AG持证）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。次要研究目的：空腹和餐后状态下，研究单次口服受试制剂缬沙坦氨氯地平片（Ⅰ）和参比制剂缬沙坦氨氯地平片（Ⅰ）（倍博特®）在健康成年受试者中的安全性。

[Translation]

Main study objectives: To study the pharmacokinetics of the test preparation valsartan amlodipine tablets (I) (specification: each tablet contains 80 mg valsartan and 5 mg amlodipine, produced by Suzhou Yushi Pharmaceutical Co., Ltd.) and the reference preparation valsartan amlodipine tablets (I) (Bebot®, specification: each tablet contains 80 mg valsartan and 5 mg amlodipine, produced by Siegfried Barbera S.L., licensed by Novartis Pharma Schweiz AG) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state. Secondary study objectives: To study the safety of the test preparation valsartan amlodipine tablets (I) and the reference preparation valsartan amlodipine tablets (I) (Bebot®) in healthy adult subjects after a single oral administration in the fasting and fed state.

Start Date18 Apr 2025

Sponsor / Collaborator

Suzhou Yushi Pharmaceutical Co Ltd.

IRCT20240803062623N6

/ RecruitingNot ApplicableIIT

Bioequivalence study of Amlodipine 10 mg Valsartan 160 mg tablet manufactured by tadbir kala jam company in comparison with Exforge (Novartis Company)

Start Date21 Nov 2024

Sponsor / Collaborator-

IRCT20230222057495N20

/ RecruitingNot Applicable

Bioequivalence study of Amlodipine (as besylate) Valsartan 160/10 mg tablets from Samisaz Pharmaceutical Company compared to Amlodipine (as besylate) Valsartan 160/10 mg tablets from Novartis Company, Turkey, under license from Switzerland, on healthy volunteers.

Start Date27 Oct 2024

Sponsor / Collaborator-

100 Clinical Results associated with Amlodipine besilate/Valsartan

100 Translational Medicine associated with Amlodipine besilate/Valsartan

100 Patents (Medical) associated with Amlodipine besilate/Valsartan

Literatures (Medical) associated with Amlodipine besilate/Valsartan

04 Oct 2022·Journal of the American Heart Association

Global Longitudinal Strain and Biomarkers of Cardiac Damage and Stress as Predictors of Outcomes After Transcatheter Aortic Valve Implantation

Article

Author: Patel, Jay N. ; Vatterott, Anna ; Gupta, Deepak K. ; Kumbhani, Dharam J. ; Baker, Michael ; Mallugari, Ravinder R. ; Clark, Daniel E. ; Jackson, Natalie ; Gillam, Linda ; Fearon, William F. ; Gonzales, Holly ; Lindman, Brian R. ; Kapadia, Samir ; Piana, Robert N. ; Kim, Juyong B. ; Perry, Andrew S. ; Zajarias, Alan ; Biersmith, Michael ; Quader, Nishath ; Stein, Elliot J. ; Bavry, Anthony A. ; Elmariah, Sammy ; Whisenant, Brian ; Coylewright, Megan ; Huang, Shi ; Welt, Frederick G.

Background:

Global longitudinal strain (GLS) is a sensitive measure of left ventricular function and a risk marker in severe aortic stenosis. We sought to determine whether biomarkers of cardiac damage (cardiac troponin) and stress (NT‐proBNP [N‐terminal pro‐B‐type natriuretic peptide]) could complement GLS to identify patients with severe aortic stenosis at highest risk.

Methods and Results:

From a multicenter prospective cohort of patients with symptomatic severe aortic stenosis who underwent transcatheter aortic valve implantation, we measured absolute GLS (aGLS), cardiac troponin, and NT‐proBNP at baseline in 499 patients. Left ventricular ejection fraction <50% was observed in 19% and impaired GLS (aGLS <15%) in 38%. Elevations in cardiac troponin and NT‐proBNP were present in 79% and 89% of those with impaired GLS, respectively, as compared with 63% and 60% of those with normal GLS, respectively ( P <0.001 for each). aGLS <15% was associated with increased mortality in univariable analysis ( P =0.009), but, in a model with both biomarkers, aGLS, and clinical covariates included, aGLS was not associated with mortality; elevation in each biomarker was associated with an increased hazard of mortality (adjusted hazard ratio, >2; P ≤0.002 for each) when the other biomarker was elevated, but not when the other biomarker was normal (interaction P =0.015).

Conclusions:

Among patients with symptomatic severe aortic stenosis undergoing transcatheter aortic valve implantation, elevations in circulating cardiac troponin and NT‐proBNP are more common as GLS worsens. Biomarkers of cardiac damage and stress are independently associated with mortality after transcatheter aortic valve implantation, whereas GLS is not. These findings may have implications for risk stratification of asymptomatic patients to determine optimal timing of valve replacement.

01 Sep 2018·Georgian medical news

[THE COMBINED THERAPY IN HYPERTENSIVE PATIENTS WITH DYSLIPIDEMIA].

Article

Author: Gegeshidze, N ; Tabukashvili, R ; Tchaava, K ; Kapetivadze, V ; Lazashvili, T ; Maglapheridze, Z

Purpose - studying of clinical efficiensy of the combined therapy (Amlodipin with Valsartan and fibrates) in hypertensive patients with dyslipidemia. Were studied 58 patients (40-65 years old) with hypertension (the level of arterial pressure was ≥140/90 and ≤180/110mm.Hg.RR). The patients have been divided into 3 groups: Group 1( n=18, middle age 55,8±5,9) were given Amlodipin 10 mg., Fenofibrates 200mg. (Lipantil); Group 2 (n=20, middle age 58,0±4,9) were given Exforge (Amlodipin 5mg./Valsartan 160mg.) and Lipantil 200mg.; Group3 (n=20, middle age 57,0±6,9) were given Exforge. Research duration- 4 months. Was done collection of anamnesis, calculation of BMI, Heart rate, Blood pressure. Before and after observation were investigated: lipid range, Total Cholesterol, Triglycerides, High Density Lipoproteins, Low Density Lipoproteins by using W.Friedwald's formula. After 4 month in group 3 was found significantly reduce of Blood Pressure, systolic- 26,6%, (р<0,001), and diastolic - 18,0%; Significantly improve Lipid range. Were decreased the levels of Total Cholesterol -14,5%, Triglycerides-15,9%, Low Density Lipoproteins -20,2%. The combined therapy by Exforge and fibrates provides effective decrease in levels of blood pressure and improvement in lipid range in hypertensive patients with dyslipidemia.

01 Sep 2014·AMERICAN JOURNAL OF THERAPEUTICS

Azilsartan, Aliskiren, and Combination Antihypertensives Utilizing Renin–Angiotensin–Aldosterone System Antagonists

Review

Author: Lanier, Gregg ; Aronow, Wilbert S ; Sankholkar, Kedar

Health care providers managing hypertension (HTN) have a large selection of pharmacologic agents to choose from, including several different classes of drugs and many similar drugs within each class. Antagonism of the renin-angiotensin-aldosterone system has been shown to be very effective for HTN, especially in patients with cardiovascular disease, diabetes, and heart failure. Within this group, there have been 2 new agents recently introduced to the US market and approved by the Food and Drug Administration. It is important for the HTN specialist to be familiar with the merits of these 2 drugs: the angiotensin receptor blocker Edarbi (azilsartan) and the renin inhibitor Tekturna (aliskiren). Additionally, there have been several new, fixed-dose combination antihypertensives introduced to the market since 2006 that use a renin-angiotensin-aldosterone antagonist. Seven of these combine 2 drugs together in a single pill: Edarbyclor (azilsartan/chlorthalidone), Exforge (amlodipine/valsartan), Azor (olmesartan/amlodipine), Twynsta (amlodipine/telmisartan), Tekturna HCT [aliskiren/hydrochlorothiazide (HCTZ)], Valturna (aliskiren/valsartan), Tekamlo (aliskiren/amlodipine). Three triple-drug combination medications have also been introduced recently: Exforge HCT (amlodipine/valsartan/HCTZ), Tribenzor (olmesartan/amlodipine/HCTZ), and Amturnide (aliskiren/amlodipine/hydrocholorothiazide). This review will summarize the trial data and important pharmacologic merits of these 2 new renin-angiotensin-aldosterone antagonists and the advantages of initiating treatment with one of the new fixed-dose, combination drugs approved over the last 5 years.

News (Medical) associated with Amlodipine besilate/Valsartan

29 Aug 2025

·www.einpresswire.com

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. Alcohol-based hand sanitizers Exposure via inhalation FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. Amlodipine and Levamlodipine Products Azor (amlodipine and olmesartan medoxomil ) Caduet (amlodipine besylate and atorvastatin calcium) Conjupri (levamlodipine maleate) Consensi (amlodipine besylate and celecoxib) Exforge (amlodipine and valsartan) Exforge HCT (amlodipine/valsartan and hydrochlorothiazide) Lotrel (amlodipine besylate and benazepril hydrochloride) Katerzia (amlodipine benzoate) Norvasc (amlodipine besylate) Prestalia (amlodipine besylate and perindopril arginine) Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide) Twynsta (amlodipine and telmisartan) Non-cardiogenic pulmonary edema FDA determined that no action is necessary at the time based on available information. Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) Injection site abscess FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Scleroderma FDA determined that no action is necessary at the time based on available information. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Cholangitis sclerosing The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling Dupixent (dupilumab) Alopecias FDA is evaluating the need for regulatory action. H.P. Acthar Gel (corticotropin) Anaphylactic and anaphylactoid responses The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. Acthar Gel labeling H.P. Acthar Gel (corticotropin) Cardiac arrhythmias The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. Acthar Gel labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) Second primary malignancy FDA determined that no action is necessary at the time based on available information. Lynparza (olaparib) Drug-induced liver injury FDA determined that no action is necessary at the time based on available information. Ocrevus (ocrelizumab) Autoimmune colitis The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. Ocrevus labeling Poteligeo (mogamulizumab-kpkc) Acute kidney injury The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. Poteligeo labeling Ravicti (glycerol phenylbutyrate) Product labeling issue regarding stability and instructions for administration The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. Ravicti labeling Spravato (esketamine) Hypertensive crisis FDA determined that no action is necessary at the time based on available information. Tremfya (guselkumab) Device use errors resulting in possible missed or partial doses The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. Tremfya labeling Trulance (plecanatide) Drug hypersensitivity The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label Trulance (plecanatide) Vomiting The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

29 Dec 2022

·www.reuters.com

Novartis to pay $245 mln to end antitrust cases over Exforge drug generics

NEW YORK, Dec 28 (Reuters) - Novartis AG (NOVN.S) said on Wednesday it will pay $245 million to end antitrust litigation accusing the Swiss drugmaker of trying to delay the launch in the United States of generic versions of its Exforge hypertension drug. The settlements with so-called direct purchasers, indirect purchasers and retailers require approval by a federal judge in Manhattan, and will resolve all outstanding claims against the company over the matter, Novartis said. CVS Health Corp (CVS.N) , Kroger Co (KR.N) , Rite Aid Corp (RAD.N) and Walgreens Boots Alliance Inc (WBA.O) are among the plaintiffs in the civil litigation, which began in 2018. The class-action litigation stemmed from a 2011 licensing agreement between Novartis and Endo International Plc's (ENDPQ.PK) Par Pharmaceutical unit. Novartis and Par were accused of entering an illegal "reverse payment" agreement to delay launches of less expensive, generic versions of Exforge, which treats hypertension to lower blood pressure and reduce the risk of strokes. Plaintiffs said Par agreed not to launch an Exforge generic for two years after the expiration of one of Novartis's patents, and Novartis agreed not to compete with Par by launching its own Exforge generic during the 180-day exclusivity period following Par's entry into the market. Novartis's annual U.S. sales of brand-name Exforge exceeded $400 million before generic versions were sold, court papers show. The case is In re Novartis and Par Antitrust Litigation, U.S. District Court, Southern District of New York, No. 18-04361. Our Standards: The Thomson Reuters Trust Principles.

License out/inPatent Infringement

100 Deals associated with Amlodipine besilate/Valsartan

External Link

KEGG	Wiki	ATC	Drug Bank
-	Amlodipine besilate/Valsartan	C09DB01	-

R&D Status

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Indication	Country/Location	Organization	Date
Hypertension	United States	Novartis Pharmaceuticals Corp.	20 Jun 2007
Essential Hypertension	European Union	Novartis Europharm Ltd.	15 Jan 2007
Essential Hypertension	Iceland	Novartis Europharm Ltd.	15 Jan 2007
Essential Hypertension	Liechtenstein	Novartis Europharm Ltd.	15 Jan 2007
Essential Hypertension	Norway	Novartis Europharm Ltd.	15 Jan 2007

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CHINA STATUS III (ESC2018)	Not Applicable	Hypertension	985	Valsartan/amlodipine fixed-dose combination	cttnlegifp(bpkdpgpcsq) = AEs were reported in 23.3% of patients umncusotco (qcpkgmzkfl ) View more	-	26 Aug 2018
NCT02062645 (CTgov)	Phase 4	Essential Hypertension	115	amlodipine/valsartan	etqdgvnntq = gaxiwdqeid algsfjzqxw (kyuuooxklq, uavojoxhxw - aosrfiagii) View more	-	28 Mar 2017
NCT01030458 (Pubmed \| J Hum Hypertens)	Phase 4	-	183	Amlodipine/valsartan 5/160 mg	efrmafnvlp(rioyrkgrps) = ankle oedema in E patients kzdbktyjnx (tzlxknxbpd )	-	01 Dec 2013
NCT01030458 (NOAAH, CTgov)	Phase 4	Hypertension	183	amlodipine 5/10 mg per day plus valsartan 160 mg/day (Amlodipine Plus Valsartan)	uzhrylohxi(ouskhbouxm) = hnzxdkohzi enrbbwxaer (gsnthhfvff, 10.7) View more	-	15 Nov 2013
				hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day (Hydrochlorothiazide Plus Bisoprolol)	uzhrylohxi(ouskhbouxm) = vhrkapgslt enrbbwxaer (gsnthhfvff, 13.1) View more
488 (ESH2012)	Not Applicable	-	366	Amlodipine/valsartan	dcncmlpvcf(cslkiudcqp) = 1.1% mhatypzxyo (jrfsoxmcts )	Positive	01 Sep 2012
NCT01167153 (EXAM STUDY \| EXAM, CTgov)	Phase 4	Hypertension	564	Valsartan/Amlodipine (Valsartan/Amlodipine)	gluyqxyqcz(njgmfdlimt) = hrwuvddpyl minxgwitzm (ppmtfxksqz, 11.69) View more	-	01 Jun 2012
				Nifedipine (Nifedipine)	gluyqxyqcz(njgmfdlimt) = ivgvomwmdh minxgwitzm (ppmtfxksqz, 12.02) View more
NCT01070043 (CTgov)	Phase 4	Hypertension	60	Valsartan	rjpubkwslb(dvsfbxtumr) = upfqafmwgw ytbrdpjwbe (nyoaijrnox, 12.71) View more	-	19 Oct 2011
NCT01001572 (CTgov)	Phase 3	Essential Hypertension	932	Placebo+Valsartan/amlodipine 160/5 mg (Valsartan/Amlodipine 160/5 mg)	snzliujynb(ksckbrngnm) = wniauuzwpz qzdzbgamzx (sosjvhuvnr, 0.39) View more	-	24 May 2011
				Placebo+Valsartan 160 mg (Valsartan 160 mg)	snzliujynb(ksckbrngnm) = pjbamfxxdc qzdzbgamzx (sosjvhuvnr, 0.40) View more
NCT00666536 (Pubmed \| Blood Press Monit)	Phase 4	Hypertension	728	Intensive treatment with amlodipine/valsartan	bcrwprikbn(jgveiiwawi) = nxothkilyp evybmnlpmj (mrmmpxpttq ) View more	-	01 Apr 2011
				Moderate treatment with amlodipine/valsartan	bcrwprikbn(jgveiiwawi) = vefzlqkejh evybmnlpmj (mrmmpxpttq )
NCT00437645 (CTgov)	Phase 3	Essential Hypertension	1,183	placebo+Valsartan 160 mg capsules+Amlodipine 5 mg capsules (Valsartan/Amlodipine 160/5 mg)	ndykmyxwkk(gkiwfwazej) = eercpeedug forbaxeiti (muhsoqebqu, 0.5944) View more	-	14 Feb 2011
				placebo+Valsartan 160 mg capsules+Amlodipine 5 mg capsules (Amlodipine 10 mg)	ndykmyxwkk(gkiwfwazej) = cglbamudis forbaxeiti (muhsoqebqu, 0.6088) View more

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