Delving into the Latest Updates on Hydrochlorothiazide/Valsartan with Synapse

主要目的：评价在健康受试者中空腹和餐后单次口服受试制剂（缬沙坦氢氯噻嗪片，深圳奥萨制药有限公司，规格：每片含缬沙坦80 mg，氢氯噻嗪12.5 mg）与参比制剂（复代文®，Novartis Pharma Schweiz AG，规格：每片含缬沙坦80 mg，氢氯噻嗪12.5 mg）的生物等效性。次要目的：观察空腹和餐后口服受试制剂和参比制剂的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of a single oral dose of the test formulation (valsartan hydrochlorothiazide tablets, Shenzhen Osa Pharmaceutical Co., Ltd., specifications: each tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide) and a reference formulation (CoDiovan®, Novartis Pharma Schweiz AG, specifications: each tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide) in healthy subjects on an empty stomach and after a meal. Secondary objective: To observe the safety of the test formulation and the reference formulation when taken orally on an empty stomach and after a meal.

Start Date29 May 2024

Sponsor / Collaborator

Shenzhen Osa Pharmaceutical Co., Ltd.

CTR20240954

/ CompletedNot Applicable

健康受试者在空腹和餐后状态下单次口服缬沙坦氢氯噻嗪片的随机、开放、两序列、两制剂、四周期、完全重复交叉的生物等效性试验

[Translation] A randomized, open-label, two-sequence, two-formulation, four-period, completely repeated crossover bioequivalence study of a single oral dose of valsartan and hydrochlorothiazide tablets in healthy subjects in the fasting and fed state

主要研究目的：试验空腹和餐后状态下单次口服受试制剂缬沙坦氢氯噻嗪片（规格：80/12.5mg（每片含缬沙坦80mg，氢氯噻嗪12.5mg），浙江金立源药业有限公司）与参比制剂缬沙坦氢氯噻嗪片（Co-Diovan®，规格：80/12.5mg（每片含缬沙坦80mg，氢氯噻嗪12.5mg），Novartis Farma S.p.A.(I)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。次要研究目的：评价健康受试者在空腹和餐后状态下，单次口服缬沙坦氢氯噻嗪片受试制剂和参比制剂后的安全性。

[Translation]

The main purpose of the study is to test the pharmacokinetics of the test preparation valsartan hydrochlorothiazide tablets (specification: 80/12.5mg (each tablet contains 80mg valsartan and 12.5mg hydrochlorothiazide), Zhejiang Jinliyuan Pharmaceutical Co., Ltd.) and the reference preparation valsartan hydrochlorothiazide tablets (Co-Diovan®, specification: 80/12.5mg (each tablet contains 80mg valsartan and 12.5mg hydrochlorothiazide), produced by Novartis Farma S.p.A. (I)) 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 purpose of the study: to evaluate the safety of the test preparation and reference preparation of valsartan hydrochlorothiazide tablets in healthy subjects after a single oral administration in the fasting and fed state.

Start Date29 May 2024

Sponsor / Collaborator

Zhejiang Kinglyuan Pharmaceutical Co. Ltd.

CTR20222172

/ CompletedNot Applicable

健康受试者在空腹和餐后状态下单次口服缬沙坦氢氯噻嗪片的随机、开放、两序列、两制剂、四周期、完全重复交叉的生物等效性试验。

[Translation] A randomized, open-label, two-sequence, two-formulation, four-period, completely repeated crossover bioequivalence study of a single oral dose of valsartan and hydrochlorothiazide tablets in healthy subjects in the fasting and fed state.

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氢氯噻嗪片（规格：80/12.5mg（每片含缬沙坦80mg，氢氯噻嗪12.5mg），浙江英格莱制药有限公司生产）与参比制剂缬沙坦氢氯噻嗪片（Co-Diovan®，规格：80/12.5mg（每片含缬沙坦80mg，氢氯噻嗪12.5mg），Novartis Farma S.p.A.(I).Italy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。次要研究目的：评价健康受试者在空腹和餐后状态下，单次口服缬沙坦氢氯噻嗪片受试制剂和参比制剂后的安全性。

[Translation]

Main study objectives: To study the pharmacokinetics of the test preparation valsartan hydrochlorothiazide tablets (specification: 80/12.5mg (each tablet contains 80mg valsartan, 12.5mg hydrochlorothiazide), produced by Zhejiang Yinggelai Pharmaceutical Co., Ltd.) and the reference preparation valsartan hydrochlorothiazide tablets (Co-Diovan®, specification: 80/12.5mg (each tablet contains 80mg valsartan, 12.5mg hydrochlorothiazide), produced by Novartis Farma S.p.A. (I).Italy) 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 evaluate the safety of the test preparation and reference preparation of valsartan hydrochlorothiazide tablets in healthy subjects after a single oral administration in the fasting and fed state.

Start Date19 Sep 2022

Sponsor / Collaborator

Zhejiang Yinggelai Pharmaceutical Co. Ltd.

100 Clinical Results associated with Hydrochlorothiazide/Valsartan

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100 Translational Medicine associated with Hydrochlorothiazide/Valsartan

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100 Patents (Medical) associated with Hydrochlorothiazide/Valsartan

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34

Literatures (Medical) associated with Hydrochlorothiazide/Valsartan

01 Feb 2024·Pharmaceutical Chemistry Journal

A Supercritical Fluid Chromatography and Tandem Mass Spectrometry Method for the Simultaneous Quantification of Valsartan and Hydrochlorothiazide in Human Plasma

Author: Agrawal, Y. K. ; Prajapati, Prajesh ; Gogoi, Parthajyoti

A simultaneous rapid, sensitive supercritical fluid chromatog. and tandem mass spectrometry method for the separation and quantification of valsartan (VAL) and hydrochlorothiazide (HCT) is developed and validated.Separation was done in a Nucleosil (250 mm x 4.6 mm) 10 mm, Nucleosil-C₁₈ column with acetonitrile modified supercritical fluid carbon dioxide (15 mL min^-1) as mobile phase.The column temperature was 45°C and the outlet pressure was set at 17 MPa.The analytes were quantitated in neg. ionization by multiple reaction monitoring (MRM) with a mass spectrometer, the mass ionizations m/z 434.2 - 350.2 and m/z 295.9 - 204.9 used to measure VAL and HCT resp.The assay exhibited a linear dynamic range of 3.2 - 3200 ng/mL for VAL and 0.8 - 800 ng/mL for HCT.The method was validated and successfully used for simultaneous determination of drugs in tablets.

01 Jan 2022·Computational and Structural Biotechnology Journal

Pharmacometabolomic study of drug response to antihypertensive medications for hypertension marker identification in Han Chinese individuals in Taiwan

Article

Author: Shiao, Ming-Shi ; Kuo, Cheng-Chin ; Chung, Chia-Min ; Xiu, Li-Li ; Chiang, Kuang-Mao ; Yang, Hsin-Chou ; Pan, Wen-Harn ; Liang, Yu-Jen ; Lo, Chi-Jen ; Cheng, Mei-Ling

Various groups of antihypertensive drugs targeting different pathways have been developed; however, the pharmacometabolic responses to these drugs have rarely been compared to elucidate the common pathway of blood pressure regulation. Here, we performed a comparative multi-dimensional pharmacometabolic study on the four major lines of antihypertensive drugs, namely angiotensin-converting enzyme inhibitors (ACEis), angiotensin receptor blockers (ARBs), calcium channel blockers (CCBs), and diuretics (DIURs), through ultra-performance liquid chromatography coupled to quantum time-of-flight mass spectrometry. Two hundred fifty patients with young-onset hypertension, who were equally divided among five study groups: non-medicated, ACEi, ARB, CCB, and DIUR groups, were recruited. In a metabolome-wide association study conducted through analysis of covariance, 37 molecular features significantly associated with pharmacometabolic responses to antihypertensive drugs were identified. One-third of these features were shared by multiple medications. ACEis, ARBs, and DIURs shared more features than CCB, partially reflecting that ACEis, ARBs, and DIURs affect the renin-angiotensin-aldosterone system. Thirteen molecular features were consistently identified by all four models of the analysis of covariance. A tandem mass spectrometry (or MS/MS) experiment was performed to decipher the chemical structure of these 13 molecular features, including ARB-associated lysophosphatidylcholine (P4135), CCB-associated diacylglycerol(15:0/18:2) (P1175), and DIUR-associated oleamide (P1516). In addition, diacylglycerol(15:0/14:2) (P408) was significantly associated with the pharmacometabolic response to all four antihypertensive drugs. The identified metabolites provide insights into the mechanisms of blood pressure regulation and potential predictive markers of pharmacometabolic responses to antihypertensive drugs.

01 Mar 2015·Journal of AOAC INTERNATIONALQ4 · AGRICULTURAL & FORESTRY SCIENCE

HPTLC with Fluorescence Densitometry for Simultaneous Determination of Some Angiotensin II Receptor Blockers in Tablets and Plasma

Q4 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: Abdallah, Mohamed Abou-El Wafa ; Hussein, Samiha Abd El-Rahman ; El-Wadood, Hanaa Mohamed Abd ; Khorshed, A Abd El-Hamid

AbstractA selective, accurate, precise, and highly sensitive HPTLC assay with reflectance/fluorescence densitometry was developed to separate and quantify some angiotensin II receptor blockers (ARBs), namely, losartan potassium, irbesartan, valsartan, and olmesartan medoxomil, in tablets and plasma. Separation of the target ARBs was performed on precoated silica gel HPTLC plates developed using chloroform–glacial acetic acid (7.5 + 2.5, v/v) mobile phase. The drugs were adequately resolved. After the exposure of the chromatograms to concentrated hydrochloric acid vapor for 10 min, the scanner was set in the reflectance/fluorescence mode with 255 nm excitation wavelength and >400 nm emission filter. The linear regression analysis data for the calibration curves of all studied drugs produced a good linear relationshipwith correlation coefficients ranging from 0.9991 to0.9999 over the concentration range of 2–20 ng/band. LOD and LOQ values of all studied drugs ranged from 0.6 to 0.8 and from 1.7 to 2.4 ng/band, respectively. The developed method was successfully applied for analysis of the target ARBs in tablets and spiked human plasma samples with good precision and accuracy.

100 Deals associated with Hydrochlorothiazide/Valsartan

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Hypertension	United States	Novartis Pharmaceuticals Corp.	06 Mar 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Essential Hypertension	Phase 1	United States	Novartis AG	01 Oct 2005
Hypertension	Phase 1	Switzerland	Novartis AG	01 Sep 2004
Hypertension	Phase 1	Germany	Novartis AG	01 Sep 2004

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EASD2014	Phase 4	Diabetes Mellitus, Type 2 \| Hypertension	130	Ramipril/hydrochlorothiazide	(pwshvllhcs) = tobpspehqt wxszfyiuba (dpfveoxqyy )	Positive	17 Sep 2014
				Valsartan/hydrochlorothiazide	(pwshvllhcs) = ddswswvnfa wxszfyiuba (dpfveoxqyy )
NCT00171561 (EASD2013)	Phase 4	Diabetes Mellitus, Type 2 \| Albuminuria soluble Klotho \| serum phosphate	-	Valsartan/hydrochlorothiazide	(ebzspcuptx) = vtsjsgalzz wvyxibnocq (fzqimbmtwd, 0.31) View more	Positive	26 Sep 2013
				Amlodipine	(ebzspcuptx) = lfopxmlxao wvyxibnocq (fzqimbmtwd, 0.49) View more
NCT00698646 (Pubmed \| Cardiovasc Drugs Ther)	Phase 4	Hypertension	384	Valsartan/Hydrochlorothiazide combination therapy	(nmmagjmuhp) = ldnbdzrhur kslsxjzwww (bwdbrkkpde )	-	01 Apr 2012
				Hydrochlorothiazide monotherapy	(nmmagjmuhp) = etvawurgkc kslsxjzwww (bwdbrkkpde )
NCT00698646 (Pubmed \| J Clin Hypertens (Greenwich))	Phase 4	Hypertension	384	valsartan/hydrochlorothiazide 160/12.5 mg	aqmlavlcxk(hwvfohvgct) = ihtsmozfim aoxgwznscy (qlpnpopjww ) View more	-	01 Oct 2011
				hydrochlorothiazide 12.5 mg	aqmlavlcxk(hwvfohvgct) = ingwxskfzq aoxgwznscy (qlpnpopjww ) View more
NCT00425997 (Pubmed \| J Clin Hypertens (Greenwich))	Phase 4	Obesity \| Hypertension	401	Combination valsartan/hydrochlorothiazide	ubmlaopxbw(rznwktmlpo) = qgrtvskqkk bujxxovant (jzpyghxslz ) View more	-	01 Oct 2011
				Amlodipine/HCTZ	ubmlaopxbw(rznwktmlpo) = igyhdceacn bujxxovant (jzpyghxslz ) View more
NCT00698646 (ValVET, CTgov)	Phase 4	Essential Hypertension	384	Valsartan (Valsartan)	ombaevrakz(ywkklgxupe) = aqrdgyyinr riimhnsigf (oihgqxlrvf, huzrsukpxy - dzhomnyluw) View more	-	15 Dec 2010
				HCTZ (HCTZ)	ombaevrakz(ywkklgxupe) = mezasckrfl riimhnsigf (oihgqxlrvf, wjfcfxwpda - yhjehcopqt) View more
VALVET (ESH2010)	Not Applicable	-	-	Valsartan/Hydrochlorothiazide 160/12.5 mg	xorczchvod(qnntlhfxhk) = zphzghxeez jslyitasfm (libuuduspy, 9.3) View more	Positive	01 Jun 2010
				Hydrochlorothiazide 12.5 mg	xorczchvod(qnntlhfxhk) = obzdfkeygr jslyitasfm (libuuduspy, 7.5) View more