Delving into the Latest Updates on Candesartan Cilexetil/Hydrochlorothiazide with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Atacand HCT, Atacand Plus, Blopress Plus

+ [14]

Target

AT1R x NCC

Action

antagonists, inhibitors

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

Takeda Pharmaceutical Co., Ltd.

Active Organization

AstraZeneca Canada, Inc.

Takeda Pharmaceutical Co., Ltd.

ANI Pharmaceuticals, Inc.

+ [3]

Inactive Organization

AstraZeneca PLC

Drug Highest PhaseApproved

First Approval Date

Sweden (03 Nov 1998),

Essential Hypertension

Regulation-

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Structure/Sequence

Molecular FormulaC40H42ClN9O10S2

InChIKeyGBMIVDMAHNBPIH-UHFFFAOYSA-N

CAS Registry1145777-98-5

主要目的：以药代动力学参数为终点指标，比较空腹和高脂餐后给药条件下，合肥合源药业有限公司生产的坎地沙坦酯氢氯噻嗪片（Ⅱ）与CHEPLAPHARM Arzneimittel GmbH持证的坎地沙坦酯氢氯噻嗪片（Ⅱ）在健康成年人群中吸收程度和速度的差异，对两制剂的生物等效性进行评价。次要目的：评价健康受试者在空腹和高脂餐后给药条件下口服受试制剂坎地沙坦酯氢氯噻嗪片（Ⅱ）和参比制剂坎地沙坦酯氢氯噻嗪片（Ⅱ）的安全性。

[Translation]

Primary objective: To compare the differences in the extent and rate of absorption of candesartan cilexetil hydrochlorothiazide tablets (Ⅱ) produced by Hefei Heyuan Pharmaceutical Co., Ltd. and candesartan cilexetil hydrochlorothiazide tablets (Ⅱ) certified by CHEPHAPHARM Arzneimittel GmbH in healthy adults under fasting and high-fat meal administration conditions using pharmacokinetic parameters as endpoints, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of oral administration of the test preparation candesartan cilexetil hydrochlorothiazide tablets (Ⅱ) and the reference preparation candesartan cilexetil hydrochlorothiazide tablets (Ⅱ) in healthy subjects under fasting and high-fat meal administration conditions.

Start Date14 Jan 2025

Sponsor / Collaborator

Hefei Cosource Pharmaceuticals, Inc.

CTR20243183

/ CompletedNot Applicable

坎地氢噻片在健康受试者中空腹/餐后、单中心、单次口服给药、随机、开放、两序列、两周期、两交叉生物等效性试验

[Translation] A single-center, single-dose, randomized, open-label, two-sequence, two-period, two-crossover bioequivalence study of candecyrrhizic tablets in healthy subjects after fasting or after meals

主要目的：考察中国健康受试者在空腹/餐后条件下单次口服河北宏鑫堂药业有限公司持有，江苏诚康药业有限公司生产的坎地氢噻片（规格：每片含坎地沙坦酯16mg和氢氯噻嗪12.5mg）与CHEPLAPHARM Arzneimittel GmbH持证的坎地氢噻片（商品名：Blopress®，规格：每片含坎地沙坦酯16mg和氢氯噻嗪12.5mg）后的体内药代动力学特征，评价两制剂的生物等效性。

[Translation]

Primary objective: To investigate the in vivo pharmacokinetic characteristics of candesartan cilexetil tablets (specification: each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide) owned by Hebei Hongxintang Pharmaceutical Co., Ltd. and produced by Jiangsu Chengkang Pharmaceutical Co., Ltd. and candesartan cilexetil tablets (trade name: Blopress®, specification: each tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide) licensed by CHEPLAPHARM Arzneimittel GmbH in healthy Chinese subjects under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations.

Start Date20 Sep 2024

Sponsor / Collaborator

Hebei Taigu Pharmaceutical Technology Co., Ltd.

CTR20243252

/ CompletedNot Applicable

坎地氢噻片在健康受试者中空腹及餐后状态下随机、开放、单剂量、两制剂、两周期、两序列交叉设计生物等效性试验方案

[Translation] A randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover bioequivalence study of candeserthi tablets in healthy subjects under fasting and fed conditions

本试验旨在研究单次空腹和餐后口服福建大谱生物医药有限公司持证、湖南九典制药股份有限公司生产的坎地氢噻片（16 mg/12.5 mg）的药代动力学特征；以CHEPLAPHARM Arzneimittel GmbH持证、Delpharm Novara S.r.l.生产的坎地氢噻片（Blopress®，16 mg/12.5 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

This study aims to study the pharmacokinetic characteristics of candecyrrhizic tablets (16 mg/12.5 mg) after single oral administration on an empty stomach or after a meal. Candecyrrhizic tablets (Blopress®, 16 mg/12.5 mg), licensed by Fujian Dapu Biopharmaceutical Co., Ltd. and produced by Hunan Jiudian Pharmaceutical Co., Ltd., were used as the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.

Start Date20 Sep 2024

Sponsor / Collaborator

Fujian Dapu Bio-pharmaceutical Co., Ltd

100 Clinical Results associated with Candesartan Cilexetil/Hydrochlorothiazide

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100 Translational Medicine associated with Candesartan Cilexetil/Hydrochlorothiazide

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100 Patents (Medical) associated with Candesartan Cilexetil/Hydrochlorothiazide

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2

Literatures (Medical) associated with Candesartan Cilexetil/Hydrochlorothiazide

01 Sep 2013·Pain PracticeQ3 · MEDICINE

Migraine Treated Using a Prophylactic Combination of Candesartan and Hydrochlorothiazide (ECARD^® Combination Tablets LD)

Q3 · MEDICINE

Article

Author: Hasegawa, Yasuhiro ; Akiyama, Hisanao

AbstractWe describe the use of the antihypertensive, candesartan, with hydrochlorothiazide (ECARD® Combination Tablets LD) as a preventive therapy that decreased the frequency of migraine accompanied by premonitory leg edema. Two women (aged 26 and 50 years) presented to hospital with an increasing frequency of migraine without aura accompanied by leg edema. We prescribed ECARD® half tablet (candesartan, 2 mg and hydrochlorothiazide, 3.125 mg), and the migraines and leg edema disappeared. The use of ECARD® to treat a series of migraines by controlling premonitory leg edema has not been reported. ECARD®, combined with a low‐dose diuretic, may have been helpful in these patients with the premonitory migraine symptom of leg edema.

01 Jan 2009·Folia Pharmacologica Japonica

Pharmacological and clinical properties of ECARD® combination tablets LD & HD, fixed-dose combination of candesartan cilexetil and hydrochlorothiazide

Review

Author: Mori, Mitsuhiro ; Tanokashira, Junichi ; Kusumoto, Keiji ; Totsuka, Nobuo

A review on concept of development of Ecard combination tablets, and pharmacol. effect including angiotensin II antagonizing effect of candesartan cilexetil referring to binding inhibitory effect on human AT₁ receptor, mode of suppression of angiotensin II-mediated contraction of rabbit isolated blood vessel, and antihypertensive effect in various hypertensive model in rats, and antihypertensive effect and diuretic effect of combination of candesartan cilexetil and hydrochlorothiazide.Also reviewed are results of clin. studies including phase III double-blind study, phase III long-term study, and pharmacokinetic study of Ecard combination tablets HD administered orally repeatedly for 15 days to light to mild essential hypertensive Japanese patients.

100 Deals associated with Candesartan Cilexetil/Hydrochlorothiazide

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	C09DA06	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	United States	ANI Pharmaceuticals, Inc.	05 Sep 2000
Essential Hypertension	Sweden	CHEPLAPHARM Arzneimittel GmbH	03 Nov 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypertension	Discovery	Romania	AstraZeneca PLC	01 Jan 2007
Hypertension	Discovery	Malta	AstraZeneca PLC	01 Jan 2007
Hypertension	Discovery	Slovakia	AstraZeneca PLC	01 Jan 2007
Hypertension	Discovery	Russia	AstraZeneca PLC	01 Jan 2007
Hypertension	Discovery	Latvia	AstraZeneca PLC	01 Jan 2007
Hypertension	Discovery	Belgium	AstraZeneca PLC	01 Jan 2007