Delving into the Latest Updates on Hydrochlorothiazide/Olmesartan Medoxomil with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Benicar HCT, Olmesartan Medoxomil and Hydrochlorothiazide, Olmesartan medoxomil/hydrochlorothiazide

+ [6]

Target

AT1R x NCC

Mechanism

AT1R antagonists(Angiotensin II Receptor Type 1 antagonists), NCC inhibitors(Thiazide-sensitive sodium-chloride cotransporter inhibitors)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

HypertensionEssential Hypertension

Inactive Indication-

Originator Organization

Daiichi Sankyo Europe GmbH

Active Organization

Daiichi Sankyo Co., Ltd.

Daiichi Sankyo Europe GmbH

Cosette Pharmaceuticals, Inc.Startup

Inactive Organization

EMS SA (Brazil)

Drug Highest PhaseApproved

First Approval Date

DE (30 Mar 2003),

Essential Hypertension

RegulationPriority Review (CN)

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Structure/Sequence

Molecular FormulaC36H38ClN9O10S2

InChIKeyCJPRWUSPLWISJM-UHFFFAOYSA-N

CAS Registry760190-74-7

评估受试制剂奥美沙坦酯氢氯噻嗪片（规格：20 mg/12.5 mg）与参比制剂奥美沙坦酯氢氯噻嗪片（复傲坦®）（规格：20 mg/12.5 mg）在健康成年受试者餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test preparation Olmesartan Medoxomil Hydrochlorothiazide Tablets (Specifications: 20 mg/12.5 mg) and the reference preparation Olmesartan Medoxomil Hydrochlorothiazide Tablets (Fuaotan®) (Specifications: 20 mg/12.5 mg) in healthy adult subjects in the fed state

主要试验目的：研究餐后状态下单次口服受试制剂奥美沙坦酯氢氯噻嗪片（规格：20 mg/12.5 mg，宁波美诺华天康药业有限公司生产）与参比制剂奥美沙坦酯氢氯噻嗪片（复傲坦®，规格：20 mg/12.5 mg；第一三共制药（上海）有限公司生产）在健康受试者体内的药代动力学特征，评价餐后状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂奥美沙坦酯氢氯噻嗪片（规格：20 mg/12.5 mg）和参比制剂奥美沙坦酯氢氯噻嗪片（复傲坦®）（规格：20 mg/12.5 mg）在健康受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation Olmesartan medoxomil hydrochlorothiazide tablets (specification: 20 mg/12.5 mg, produced by Ningbo Menohua Tiankang Pharmaceutical Co., Ltd.) and the reference preparation Olmesartan medoxomil hydrochlorothiazide tablets (Fuaotan®, specification: 20 mg/12.5 mg; produced by Daiichi Sankyo Pharmaceutical (Shanghai) Co., Ltd.) in healthy subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. Secondary purpose of the study: to study the safety of the test preparation Olmesartan medoxomil hydrochlorothiazide tablets (specification: 20 mg/12.5 mg) and the reference preparation Olmesartan medoxomil hydrochlorothiazide tablets (Fuaotan®) (specification: 20 mg/12.5 mg) in healthy subjects.

Start Date11 Jun 2022

Sponsor / Collaborator

Ningbo Krka Menovo Pharmaceutical Co., Ltd.

CTR20221127

/ CompletedNot Applicable

评估受试制剂奥美沙坦酯氢氯噻嗪片（规格：20 mg/12.5 mg）与参比制剂奥美沙坦酯氢氯噻嗪片（复傲坦®）（规格：20 mg/12.5 mg）在健康成年受试者空腹状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test preparation Olmesartan Medoxomil Hydrochlorothiazide Tablets (Specifications: 20 mg/12.5 mg) and the reference preparation Olmesartan Medoxomil Hydrochlorothiazide Tablets (Fuaotan®) (Specifications: 20 mg/12.5 mg) in healthy adult subjects under fasting state

主要试验目的：研究空腹状态下单次口服受试制剂奥美沙坦酯氢氯噻嗪片（规格：20 mg/12.5 mg，宁波美诺华天康药业有限公司生产）与参比制剂奥美沙坦酯氢氯噻嗪片（复傲坦®，规格：20 mg/12.5 mg；第一三共制药（上海）有限公司生产）在健康受试者体内的药代动力学特征，评价空腹状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂奥美沙坦酯氢氯噻嗪片（规格：20 mg/12.5 mg）和参比制剂奥美沙坦酯氢氯噻嗪片（复傲坦®）（规格：20 mg/12.5 mg）在健康受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation Olmesartan medoxomil hydrochlorothiazide tablets (specification: 20 mg/12.5 mg, produced by Ningbo Menohua Tiankang Pharmaceutical Co., Ltd.) and the reference preparation Olmesartan medoxomil hydrochlorothiazide tablets (Fuaotan®, specification: 20 mg/12.5 mg; produced by Daiichi Sankyo Pharmaceutical (Shanghai) Co., Ltd.) in healthy subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting conditions. Secondary purpose of the study is to study the safety of the test preparation Olmesartan medoxomil hydrochlorothiazide tablets (specification: 20 mg/12.5 mg) and the reference preparation Olmesartan medoxomil hydrochlorothiazide tablets (Fuaotan®) (specification: 20 mg/12.5 mg) in healthy subjects.

Start Date07 Jun 2022

Sponsor / Collaborator

Ningbo Krka Menovo Pharmaceutical Co., Ltd.

100 Clinical Results associated with Hydrochlorothiazide/Olmesartan Medoxomil

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100 Translational Medicine associated with Hydrochlorothiazide/Olmesartan Medoxomil

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100 Patents (Medical) associated with Hydrochlorothiazide/Olmesartan Medoxomil

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2

Literatures (Medical) associated with Hydrochlorothiazide/Olmesartan Medoxomil

01 Mar 2007·Revue medicale de Liege

[Medication of the month. Olmesartan medoxomil hydroclorothiazide (Olmetec Plus or Belsar Plus].

Review

Author: Lancellotti, P

The therapeutic control of hypertension is still a global challenge and frequently requires combination therapy. Olmesartan medoxomil hydrochlorothiazide (Olmetec plus, Belsar plus) is a fixed-dose combination of olmesartan 20 mg and hydrochlorothiazide 12.5 or 25 mg. Olmesartan is a well known angiotensin II AT1 receptor blocker characterized by a good efficacy, a fast and prolonged duration of action and a placebo-like tolerability. With the combination therapy, no significant change of pharmacokinetics of either component is observed. The fixed-dose combination results in a greater blood pressure reduction compared to monotherapy with either component. This is at least effective as or even more effective than the combination of atenolol or losartan with hydrochlorothiazide, respectively. The responder rate is about 90%. The safety and tolerability remain excellent. Beyond the antihypertensive effect, olmesartan significantly reduces vascular inflammation and the wall-to-lumen ration in arteries. The starting dose is 20/12.5 mg.

01 Jun 1990·American Journal of HypertensionQ3 · MEDICINE

Effect of Dopamine on Renal Blood Flow, Prostaglandins, Renin and Electrolyte Excretion in Normal and Hypertensive Humans

Q3 · MEDICINE

Article

Author: S. Bughi ; J. Nadler ; R. Horton ; E. Jost-Vu ; I. Antonipillai

A low dose of dopamine (1 microgram/min/kg) infused for 3 h, which is without systemic hemodynamic effects in normal subjects, increased the renal blood flow and renal production of prostacyclin (PGI2). This action was blocked by metoclopramide as well as by either of two cyclooxygenase (CO) blockers, but effects were not altered by administration of the alpha 1 blocker prazosin. Much of the effect of dopamine (DA) is apparently via the DA1 receptor, since fenoldopam (0.1 microgram/min/kg) reproduced these actions. However, although fenoldopam increased glomerular filtration rate and urinary Na+, CO blockers were without effect. In contrast neither DA or fenoldopam infusions changed either renal blood flow or PGI2 in a group of patients with essential hypertension. Renin secretion was shown to be increased via DA1 receptor activation both in humans and rat renal tissue. The DA2 receptor may also play a role since domperidone can reduce renal blood flow.

100 Deals associated with Hydrochlorothiazide/Olmesartan Medoxomil

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	C09DA08	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	US	Cosette Pharmaceuticals, Inc.Startup	05 Jun 2003
Essential Hypertension	DE	Daiichi Sankyo Europe GmbH	30 Mar 2003

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Essential Hypertension	Phase 1	SK	Daiichi Sankyo Co., Ltd.	01 Feb 2007
Essential Hypertension	Phase 1	BG	Daiichi Sankyo Co., Ltd.	01 Feb 2007
Essential Hypertension	Phase 1	CZ	Daiichi Sankyo Co., Ltd.	01 Feb 2007
Essential Hypertension	Phase 1	PL	Daiichi Sankyo Co., Ltd.	01 Feb 2007
Essential Hypertension	Phase 1	UA	Daiichi Sankyo Co., Ltd.	01 Feb 2007
Essential Hypertension	Preclinical	FR	Daiichi Sankyo Co., Ltd.	01 Feb 2007
Essential Hypertension	Preclinical	NL	Daiichi Sankyo Co., Ltd.	01 Feb 2007
Essential Hypertension	Preclinical	BE	Daiichi Sankyo Co., Ltd.	01 Feb 2007
Essential Hypertension	Preclinical	ES	Daiichi Sankyo Co., Ltd.	01 Feb 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00430950 \| EUCTR2006-003876-37-CZ \| NCT00430508 (Pubmed \| Curr Med Res Opin)	Not Applicable	Hypertension, severe	-	Olmesartan 40 mg	szlpqjhftr(kbcwanfhsf) = gzkruilkhm pyfdvqrivv (jdrlksnxgq )	-	01 Feb 2012
				Olmesartan/hydrochlorothiazide 20/12.5 mg	szlpqjhftr(kbcwanfhsf) = zuogsdtjsy pyfdvqrivv (jdrlksnxgq )
PP.5.203 (ESH2010)	Not Applicable	-	-	Olmesartan Medoxomil/Hydrochlorothiazide 40/25mg	kobvpsubmw(dpizaavnfv) = ykcbatzbji gvtlktjmql (vzfzlamynh ) View more	Positive	01 Jun 2010
				Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg	kobvpsubmw(dpizaavnfv) = pdxzdyjnmh gvtlktjmql (vzfzlamynh ) View more
PP.5.205 (ESH2010)	Not Applicable	Hypertension, severe	-	Olmesartan 40 mg	zunycxpygv(rtlcdpxnbd) = vsijaqzzxi khsfkonxmy (xfozjqfwya ) View more	Positive	01 Jun 2010
				Olmesartan/Hydrochlorothiazide 40/12.5 mg	zunycxpygv(rtlcdpxnbd) = rjwughxkoh khsfkonxmy (xfozjqfwya ) View more