主要目的：在健康男性与女性受试者中于餐后条件下，评价受试制剂氨氯地平贝那普利胶囊【规格：每粒含苯磺酸氨氯地平5 mg（以氨氯地平计）和盐酸贝那普利10 mg，生产商：浙江华海药业股份有限公司】和Novartis Pharmaceuticals Corp为持证商的参比制剂氨氯地平贝那普利胶囊【Lotrel，规格：每粒含苯磺酸氨氯地平5 mg（以氨氯地平计）和盐酸贝那普利10 mg】的生物等效性。次要目的：观察受试制剂氨氯地平贝那普利胶囊与参比制剂氨氯地平贝那普利胶囊（Lotrel）在健康受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the test preparation Amlodipine Benazepril Capsules [Specification: Each capsule contains 5 mg of amlodipine besylate (calculated as amlodipine) and 10 mg of benazepril hydrochloride, manufacturer: Zhejiang Huahai Pharmaceutical Co., Ltd.] and the reference preparation Amlodipine Benazepril Capsules [Lotrel, Specification: Each capsule contains 5 mg of amlodipine besylate (calculated as amlodipine) and 10 mg of benazepril hydrochloride] of Novartis Pharmaceuticals Corp. in healthy male and female subjects under postprandial conditions. Secondary objective: To observe the safety of the test preparation Amlodipine Benazepril Capsules and the reference preparation Amlodipine Benazepril Capsules (Lotrel) in healthy subjects.

Start Date01 Mar 2025

Sponsor / Collaborator

Zhejiang Huahai Pharmaceutical Co., Ltd.

CTR20250421

/ CompletedNot Applicable

氨氯地平贝那普利胶囊（5 mg/10 mg）在健康受试者中空腹条件下的生物等效性试验

[Translation] Bioequivalence study of amlodipine and benazepril capsules (5 mg/10 mg) in healthy volunteers under fasting conditions

主要目的：在健康男性与女性受试者中于空腹条件下，评价受试制剂氨氯地平贝那普利胶囊【规格：每粒含苯磺酸氨氯地平5 mg（以氨氯地平计）和盐酸贝那普利10 mg，生产商：浙江华海药业股份有限公司】和Novartis Pharmaceuticals Corp为持证商的参比制剂氨氯地平贝那普利胶囊【Lotrel，规格：每粒含苯磺酸氨氯地平5 mg（以氨氯地平计）和盐酸贝那普利10 mg】的生物等效性。次要目的：观察受试制剂氨氯地平贝那普利胶囊与参比制剂氨氯地平贝那普利胶囊（Lotrel）在健康受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the test preparation Amlodipine Benazepril Capsules [Specification: Each capsule contains 5 mg of amlodipine besylate (calculated as amlodipine) and 10 mg of benazepril hydrochloride, manufacturer: Zhejiang Huahai Pharmaceutical Co., Ltd.] and the reference preparation Amlodipine Benazepril Capsules [Lotrel, Specification: Each capsule contains 5 mg of amlodipine besylate (calculated as amlodipine) and 10 mg of benazepril hydrochloride] of Novartis Pharmaceuticals Corp. in healthy male and female subjects under fasting conditions. Secondary objective: To observe the safety of the test preparation Amlodipine Benazepril Capsules and the reference preparation Amlodipine Benazepril Capsules (Lotrel) in healthy subjects.

Start Date19 Feb 2025

Sponsor / Collaborator

Zhejiang Huahai Pharmaceutical Co., Ltd.

CTR20243734

/ CompletedNot Applicable

左氨氯地平贝那普利胶囊在中国成年健康受试者中的生物等效性研究

[Translation] Study on the bioequivalence of levoamlodipine-benazepril capsules in healthy Chinese adult subjects

主要研究目的：研究空腹/餐后状态下口服受试制剂左氨氯地平贝那普利胶囊（江西施美药业股份有限公司生产）与参比制剂【苯磺酸氨氯地平片（络活喜，辉瑞制药有限公司生产）和盐酸贝那普利片（洛汀新，北京诺华制药有限公司生产）各1片】在中国健康成年受试者体内的药代动力学特征，评价空腹/餐后状态口服两种制剂的生物等效性。次要研究目的：评估受试制剂左氨氯地平贝那普利胶囊和参比制剂【苯磺酸氨氯地平片（络活喜，辉瑞制药有限公司生产）和盐酸贝那普利片（洛汀新，北京诺华制药有限公司生产）各1片】在中国健康成年受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation levamlodipine benazepril capsule (produced by Jiangxi Shimei Pharmaceutical Co., Ltd.) and the reference preparation [1 tablet each of amlodipine besylate tablets (Norvasc, produced by Pfizer Pharmaceutical Co., Ltd.) and benazepril hydrochloride tablets (Lotensin, produced by Beijing Novartis Pharmaceutical Co., Ltd.)] in healthy Chinese adult subjects in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary purpose of the study is to evaluate the safety of the test preparation levamlodipine benazepril capsule and the reference preparation [1 tablet each of amlodipine besylate tablets (Norvasc, produced by Pfizer Pharmaceutical Co., Ltd.) and benazepril hydrochloride tablets (Lotensin, produced by Beijing Novartis Pharmaceutical Co., Ltd.)] in healthy Chinese adult subjects.

Start Date31 Oct 2024

Sponsor / Collaborator

Jiangxi Shimei Pharmaceutical Co., Ltd.

100 Clinical Results associated with Amlodipine Besylate/Benazepril Hydrochloride

100 Translational Medicine associated with Amlodipine Besylate/Benazepril Hydrochloride

100 Patents (Medical) associated with Amlodipine Besylate/Benazepril Hydrochloride

Literatures (Medical) associated with Amlodipine Besylate/Benazepril Hydrochloride

01 Sep 2022·Annals of palliative medicine

Hypertension as a rare adverse effect caused by infliximab in the treatment of Crohn’s disease: a case report

Author: Mo, Jiahao ; Zhao, Xiying ; Tang, Jian ; Zhang, Beiping

BACKGROUND:

Infliximab is an effective drug for the treatment of Crohn's disease. As a rare and unique adverse effect of infliximab, hypertension should be paid enough attention in clinical work. At present, there is no relevant case report. We report a case of a 38-year-old man with Crohn's disease who had no history of hypertension and developed hypertension symptoms during infliximab treatment.

CASE DESCRIPTION:

The patient was treated with 5 mg/kg infliximab on August 27, 2020. From August 27, 2020 to October 20, 2020, the patient underwent 3 treatment sessions. After each injection of infliximab, the patient's blood pressure became elevated, accompanied by dizziness and symmetrical numbness of both lower limbs. Amlodipine benazepril tablets were given orally to control blood pressure. Under close monitoring, 5 mg/kg infliximab was used again. After 10 min of infusion, blood pressure rose to 160/118 mmHg. Infusion was discontinued immediately, after which blood pressure decreased to normal. Adrenal computed tomography did not indicate adrenal hyperplasia or space occupying lesions, and the detection of hypertension related indicators in standing and supine position was abnormal. Since follow up, the patient has stopped using infliximab and has had no hypertension-related symptoms, even without antihypertensives. Measured blood pressure was within the normal range.

CONCLUSIONS:

Hypertension, as one of the rare adverse reactions of infliximab in the treatment of Crohn's disease, should be paid enough attention.

01 Jul 2013·American journal of hypertensionQ3 · MEDICINE

Dynamic View on Affordability of Fixed-Dose Combination Antihypertensive Drug Therapy

Q3 · MEDICINE

Article

Author: Wang, Junling ; Hong, Song Hee ; Tang, Jun

BACKGROUND:

The use of fixed-dose combinations (FDCs) has been increasing since the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure recommended using ≥2 drugs as the first-line drug therapy for patients with stage 2 hypertension. FDCs simplify the drug therapy regimen and reportedly lower the drug therapy cost compared with the free combination (FC) of 2 single-agent drugs. This study hypothesized that the affordability of FDCs over FCs would change over time depending on the availability of generic single-agent drugs.

METHODS:

This study used the 2009 Medical Expenditure Panel Survey. Antihypertensive drugs were identified based on the Food and Drug Administration national drug directory. Based on the 2 databases, regression models were run to predict average monthly drug cost as well as out-of-pocket cost for each prescription along with their 95% confidence intervals (CIs).

RESULTS:

Overall, FDCs (n = 26) had average monthly drug costs similar to respective FCs when FCs were not generically available. However, when FCs were generically available, FDCs (n = 11) had average drugs costs much higher than their respective FCs. For example, Lotrel as an FDC had an average monthly drug cost of $115.97 (95% CI = $96.59-$135.36), whereas its counterpart FC had an average monthly drug cost of $21.00 (95% CI = $18.23-$23.79).

CONCLUSIONS:

The cost advantage of FDCs over FCs was reversed when FCs were generically available. The finding of this study informs patients, health-care providers, and drug plans of the importance of making dynamic decisions on preferred drug therapy options depending on the availability of generic drugs.

01 Nov 2008·Kidney internationalQ1 · MEDICINE

Diuretics should be used as the second-line agent in combination with RAS inhibitors in ptoteinuric patients with CKD

Q1 · MEDICINE

Letter

Author: Michio Fukuda ; Genjiro Kimura

A review.This paper describes the Gauging Albuminuria Reduction With Lotrel in Diabetic Patients With Hypertension (GUARD) study.The GUARD study showed that combination of an angiotensin-converting enzyme inhibitor (ACEi) with a diuretic significantly reduced albuminuria more than combination with a calcium channel blocker in patients with type 2 diabetes.Generally, it can be stated that diuretics should be used as the second-line antihypertensive agent for proteinuric patients with chronic kidney disease, in combination with renin-angiotensin system inhibitors to reduce proteinuria and to preserve renal function.

News (Medical) associated with Amlodipine Besylate/Benazepril Hydrochloride

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

21 May 2007

·www.biospace.com

Teva Pharmaceutical Industries Limited Provides Update on Generic Lotrel® Litigation

JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the United States District Court for the District of New Jersey has vacated a temporary order restraining Teva's launch of its amlodipine besylate/benazepril products, AB rated to Novartis' Lotrel®. Instead, the Court has ordered Teva and Novartis not to sell or offer further generic product, beyond what has already been commercialized, including any authorized generics, until at least the completion of a status call with the Judge next Tuesday, May 29, 2007.

Generic Drug

100 Deals associated with Amlodipine Besylate/Benazepril Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Amlodipine Besylate/Benazepril Hydrochloride	C02N	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hypertension	United States	Sandoz, Inc.	03 Mar 1995

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Essential Hypertension	Phase 3	United States	Novartis AG	01 Jul 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01375322 (Pubmed \| Clin Ther)	Phase 4	Diabetes Mellitus, Type 2 \| Hypertension	226	Amlodipine/Benazepril	ynhukujywb(fhaqcasmui) = more frequently reported in the amlodipine/benazepril group than in the valsartan/hydrochlorothiazide group awheinaqlm (iblwgsztsf )	-	01 Aug 2012
NCT00170950 (ACCOMPLISH, CTgov)	Phase 3	Hypertension	11,506	Benazepril/amlodipine 40/10 mg (Benazepril/Amlodipine)	acqcaradue = hcdsqwnjza oqbwziofia (gpegrmroby, rvprmrdwut - frhodfdcxd) View more	-	17 May 2011
				Benazepril/hydrochlorothiazide 40/25 mg (Benazepril/Hydrochlorothiazide)	acqcaradue = fmbccdxtrb oqbwziofia (gpegrmroby, uomgblwjqd - tzqltatois) View more
NCT00834977 (CTgov)	Phase 1	-	48	Amlodipine-benazepril 10 mg-20 mg capsules (Amlodipine Benazepril)	iiwfpvzrbh(rptsptlzal) = jojusliemm wtwijqvjlg (rbbwptspgx, 1917.69) View more	-	18 Aug 2009
				Lotrel® (Lotrel®)	iiwfpvzrbh(rptsptlzal) = fmlqutmizw wtwijqvjlg (rbbwptspgx, 1697.24) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis