[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of irbesartan and hydrochlorothiazide tablets in healthy adult Chinese subjects

考察空腹和餐后单次口服受试制剂厄贝沙坦氢氯噻嗪片（规格：150mg/12.5mg：每片含厄贝沙坦150mg，氢氯噻嗪12.5mg，宁波美诺华天康药业有限公司生产）与参比制剂厄贝沙坦氢氯噻嗪片（商品名：安博诺®；COAPROVEL®，规格：150mg/12.5mg：每片含厄贝沙坦150mg，氢氯噻嗪12.5mg，Sanofi Winthrop Industrie 生产），在中国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。次要研究目的：评价空腹和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]

To investigate the relative bioavailability of the test preparation irbesartan hydrochlorothiazide tablets (specification: 150mg/12.5mg: each tablet contains 150mg irbesartan and 12.5mg hydrochlorothiazide, produced by Ningbo Menohua Tiankang Pharmaceutical Co., Ltd.) and the reference preparation irbesartan hydrochlorothiazide tablets (trade name: Ambron®; COAPROVEL®, specification: 150mg/12.5mg: each tablet contains 150mg irbesartan and 12.5mg hydrochlorothiazide, produced by Sanofi Winthrop Industrie) in healthy Chinese subjects after single oral administration on an empty stomach and after a meal, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations. Secondary study objectives: To evaluate the safety of the test preparation and the reference preparation in healthy Chinese adult subjects after single oral administration on an empty stomach and after a meal.

Start Date06 Mar 2024

Sponsor / Collaborator

Hangzhou New Novartis Pharmaceutical Co., Ltd.

CTR20233514

/ CompletedNot Applicable

单中心、随机、开放、两周期、交叉设计评价中国健康受试者单次空腹及餐后口服厄贝沙坦氢氯噻嗪片的人体生物等效性试验

[Translation] A single-center, randomized, open-label, two-period, crossover design study to evaluate the bioequivalence of fasting and fed oral irbesartan and hydrochlorothiazide tablets in healthy Chinese subjects

主要研究目的:以Sanofi Winthrop Industrie生产的厄贝沙坦氢氯噻嗪片（商品名：安博诺；规格：厄贝沙坦150mg和氢氯噻嗪12.5mg）为参比制剂，以江西施美药业股份有限公司研发的厄贝沙坦氢氯噻嗪片（规格：厄贝沙坦150mg和氢氯噻嗪12.5mg）为受试制剂，通过单中心、随机、开放、两周期、交叉设计的生物等效性试验来评价两种制剂在空腹及餐后条件下的生物等效性。次要研究目的:评估受试制剂厄贝沙坦氢氯噻嗪片和参比制剂安博诺在中国健康成年受试者中的安全性。

[Translation]

The main purpose of the study was to use irbesartan hydrochlorothiazide tablets (trade name: Ambono; specifications: irbesartan 150mg and hydrochlorothiazide 12.5mg) produced by Sanofi Winthrop Industrie as the reference preparation and irbesartan hydrochlorothiazide tablets (specifications: irbesartan 150mg and hydrochlorothiazide 12.5mg) developed by Jiangxi Shimei Pharmaceutical Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations under fasting and postprandial conditions through a single-center, randomized, open, two-period, crossover design bioequivalence trial. Secondary purpose of the study was to evaluate the safety of the test preparation irbesartan hydrochlorothiazide tablets and the reference preparation Ambono in healthy adult subjects in China.

Start Date22 Dec 2023

Sponsor / Collaborator

Jiangxi Shimei Pharmaceutical Co., Ltd.

CTR20233900

/ CompletedNot Applicable

厄贝沙坦氢氯噻嗪片人体生物等效性研究

[Translation] Study on the bioequivalence of irbesartan and hydrochlorothiazide tablets in healthy volunteers

主要目的：本试验旨在研究单次空腹和餐后口服广州白云山天心制药股份有限公司研制、生产的厄贝沙坦氢氯噻嗪片（厄贝沙坦150 mg/氢氯噻嗪12.5 mg）的药代动力学特征；以Sanofi Winthrop Industrie生产的厄贝沙坦氢氯噻嗪片（安博诺®，厄贝沙坦150 mg/氢氯噻嗪12.5 mg）为参比制剂，比较两制剂的药动学参数，评价两种制剂的生物等效性。次要目的：观察评估空腹和餐后状态条件下单次口服受试制剂厄贝沙坦氢氯噻嗪片和参比制剂厄贝沙坦氢氯噻嗪片（商品名：安博诺®）在中国健康受试者成年人群中的安全性。

[Translation]

Primary objective: This study aims to study the pharmacokinetic characteristics of irbesartan hydrochlorothiazide tablets (irbesartan 150 mg/hydrochlorothiazide 12.5 mg) developed and produced by Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd. after single oral administration on an empty stomach and after a meal; irbesartan hydrochlorothiazide tablets (Anbono®, irbesartan 150 mg/hydrochlorothiazide 12.5 mg) produced by Sanofi Winthrop Industrie were used as the reference preparation to compare the pharmacokinetic parameters of the two preparations and evaluate the bioequivalence of the two preparations. Secondary objective: To observe and evaluate the safety of the test preparation irbesartan hydrochlorothiazide tablets and the reference preparation irbesartan hydrochlorothiazide tablets (trade name: Anbono®) in Chinese healthy adult subjects after a single oral administration on an empty stomach and after a meal.

Start Date07 Dec 2023

Sponsor / Collaborator

Guangzhou Baiyunshan Tianxin Pharmaceutical Co. Ltd.

100 Clinical Results associated with Hydrochlorothiazide/Irbesartan

100 Translational Medicine associated with Hydrochlorothiazide/Irbesartan

100 Patents (Medical) associated with Hydrochlorothiazide/Irbesartan

Literatures (Medical) associated with Hydrochlorothiazide/Irbesartan

01 Jun 2022·Journal of Hypertension

OBSERVATIONAL PROSPECTIVE STUDY OF AZILSARTAN MEDOXOMIL/ CHLORTALIDONE COMPARED WITH IRBESARTAN/ HYDROCHLOROTHIAZIDE COMBINATION THERAPY IN OBESE HYPERTENSIVES (PUZZLE)

Article

Author: Vasyuk, Yury ; Shupenina, Elena ; Namazova, Gulnar

Objective:Attainment of blood pressure (BP) control is important to successful management of arterial hypertension (AH). It is more difficult to reach recommended BP goals in obese hypertensives. Combination of ARB and thiazide diuretics is recommended. Azilsartan medoxomil/chlorthalidone (AZL-C) is potent and currently the only fixed combination of ARB and thiazide-like diuretic used for AH. The objective of this study was to evaluate influence of AZL-C on office, 24-hour brachial, central blood pressure and aortic stiffness parameters compared with irbesartan/hydrochlorothiazide (IRB-H).Design and method:We included 94 patients 35–55 years old with I-II grade AH and obesity at high cardiovascular risk. Patients with symptomatic organ damage, intolerance of ARB, thiazide diuretics, secondary AH were exluded. All patients underwent phisical exam, office, ambulatory BP measurement with arterial stiffness analysis on inclusion, during 1, 3 and 6 months visit. After inclusion 47 patients received AZL-C dose 40/12.5 or 40/25 mg, 47 patients received IRB-H dose 150/12.5 or 300/25 mg. The study was approved by local ethic committee and registered on clinicaltrials.gov (NCT03006796).Results:On 1 month visit 37(79%) patients reached office BP goals in AZL-C group vs 32(68%) in IRB-H, finally the proportion was 45(96%) vs 41(87%). After 3 months significantly more patients received higher doses of IRB-H: 18(38%) vs 9(19%) in AZL-C group. The mean office systolic/diastolic BP on the final visit was 126,4/84,5 in AZL-C vs 132,7/89,9 mmHg in IRB-H group. The mean ambulatory SBP/DBP was 124,6/77,6 in AZL-C vs 127,4/81,7 mmHg in IRB-H group. After 6 months the mean ambulatory central SBP and aortic augmentation index reduced in both groups, more significantly in AZL-C patients: from 129,4 to 115,3 vs. from 129,5 to 117,6 mmHg in IRB-H group; from 26% to 17% vs. from 28% to 21% in IRB-H. There were no changes in ambulatory PWV in both groups, which may be due to the variability of this parameter during the day.Conclusions:Both fixed combinations of ARB and diuretic are safe and effective treatment of AH in obese patients, but long-term treatment with AZL-C allows to achieve more stable peripheral and central BP decrease.

01 Jan 2021·American journal of translational researchQ3 · MEDICINE

Effect of Tripterygium wilfordii polyglycoside tablets on serum inflammatory factors and T cells in patients with chronic nephritis.

Q3 · MEDICINE

Article

Author: Zhao, Jisheng ; Yuan, Hui ; Li, Qingzhen ; Liu, Peipei ; Huang, Yong

OBJECTIVEInvestigate the effect of Tripterygium wilfordii polyglycoside tablets on serum inflammatory factors and T cells in patients with chronic nephritis.METHODSA total of 89 patients with chronic nephritis were randomly divided into a control group (44 cases, treated with irbesartan hydrochlorothiazide combined with dipyridamole) and an observation group (45 cases, treated with Tripterygium wilfordii polyglycoside tablets based on irbesartan hydrochlorothiazide and dipyridamole like the control group). Patients in both groups were treated for two months. The renal function, inflammatory factors, the proportion of T lymphocyte subsets, and 24 h urinary protein quantification (24 h Upro) of patients with hemodialysis were compared between the two groups before and after treatment. The occurrence of adverse reactions was recorded.RESULTSSCR, BUN levels, 24 h Upro, serum hs-CRP, TNF-α, and IL-8 levels in the two groups after treatment were lower than those before treatment, and those of the observation group were lower than those of the control group (all P<0.05). After treatment, the CD4+ ratio and CD4+/CD8+ ratio of the two groups of patients increased, while the CD8+ ratio decreased. The changes in the observation group were greater than those in the control group (all P<0.05). There was no significant difference in the incidence of total adverse reactions between the two groups during treatment (P>0.05).CONCLUSIONTreatment combined with Tripterygium wilfordii polyglycosides can significantly alleviate the inflammatory state of patients with chronic glomerulonephritis, reduce the level of proteinuria, and improve renal function. Tripterygium wilfordii polyglycosides can improve immune function of the body and has high safety.

01 Feb 2014·Journal of Pharmaceutical and Biomedical AnalysisQ3 · MEDICINE

Low level drug product API form analysis – Avalide tablet NIR quantitative method development and robustness challenges

Q3 · MEDICINE

Article

Author: Grosso, John ; Yin, Shawn ; Pan, Duohai ; Crull, George

Avalide(@), a medication used for the treatment of hypertension, is a combination of Irbesartan, and Hydrochlorothiazide. Irbesartan, one of the active pharmaceutical ingredients (API) in Avalide products, exists in two neat crystalline forms: Form A and Form B. Irbesartan Form A is the API form used in a wet granulation for the preparation of Avalide tablets. The presence of the less soluble Irbesartan Form B in Avalide tablets may result in the slower dissolution. In this paper, we have presented our work on the method development, verification and challenges of quantitatively detecting, via NIR and ssNMR, very small amounts of Irbesartan Form B in Avalide tablets. As part of the NIR method development and qualification, limit of detection, linearity and accuracy were examined. In addition, a limited study of the robustness of the method was conducted and a bias in the level of Form B was correlated to the ambient humidity. ssNMR, a primary method for the determination of polymorphic composition, was successfully used as an orthogonal technique to verify the accuracy of the NIR method and added to the confidence in the NIR method. The speed and efficiency of the NIR method make it a suitable and convenient tool for routine analysis of Avalide tablets for Form B in a QC environment.

100 Deals associated with Hydrochlorothiazide/Irbesartan

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	C09DA04	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Essential Hypertension	IS	Sanofi Winthrop Industrie SA	14 Oct 1998
Essential Hypertension	EU	Sanofi Winthrop Industrie SA	14 Oct 1998
Essential Hypertension	LI	Sanofi Winthrop Industrie SA	14 Oct 1998
Essential Hypertension	NO	Sanofi Winthrop Industrie SA	14 Oct 1998
Hypertension	US	Sanofi-Aventis U.S. LLC	30 Sep 1997

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypertension	Phase 1	NL	Sanofi	01 Sep 2004
Hypertension	Phase 1	IL	Sanofi	01 Sep 2004
Hypertension	Phase 1	DE	Sanofi	01 Sep 2004
Hypertension	Discovery	RU	Bristol Myers Squibb Co.	01 Sep 2004
Hypertension	Discovery	RU	Sanofi	01 Sep 2004
Hypertension	Discovery	BE	Sanofi	01 Sep 2004

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEHIS STUDY (ESH2015)	Not Applicable	Hypertension	124	Nebivolol 5 mg/Hydrochlorothiazide 12.5 mg	sokpvhdvrm(wzhtjgjjkd) = ptrniizjft bzqhmhopcj (tiyysbtgaq ) View more	Positive	01 Jun 2015
				Irbesartan 150 mg/Hydrochlorothiazide 12.5 mg	sokpvhdvrm(wzhtjgjjkd) = dvztpcfwyk bzqhmhopcj (tiyysbtgaq ) View more
NCT00708344 (ACTUAL, Pubmed \| Blood Press)	Phase 4	Hypertension	833	irbesartan/hydrochlorothiazide (Early titration group)	ptydpuzxfy(qcntstqatm) = Serious adverse events were more frequent in E (2.5% vs 0.7%) pojueepcoo (uybwpaaimm )	-	01 Dec 2011
				irbesartan/hydrochlorothiazide (Late titration group)

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