Evaluation of efficacy in improvement of cardiac function / renal function by REZALTAS COMBINATION TABLETS on hypertension patient. - Evaluation of efficacy of REZALTAS COMBINATION TABLETS on hypertension patient.

开始日期2011-03-01

申办/合作机构

Kanazawa University Hospital

JPRN-jRCT2080220439 / Unknown status临床3期

Open-label, phase III study of CS-866AZ

开始日期2007-09-12

申办/合作机构-

NCT00454662 / Completed临床4期IIT

Combination of OLMesartan and Calcium Channel Blocker or Low Dose Diuretics in High Risk Elderly Hypertensive Patients Study (COLM-Study)

The purpose of this study is to investigate which combination therapy is more effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients: AT1 subtype angiotensin II receptor antagonist/calcium channel blocker or AT1 subtype angiotensin II receptor antagonist/low dose diuretic.

开始日期2007-04-01

申办/合作机构

Japan Heart Foundation

100 项与奥美沙坦酯/阿折地平相关的临床结果

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100 项与奥美沙坦酯/阿折地平相关的转化医学

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100 项与奥美沙坦酯/阿折地平相关的专利（医药）

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项与奥美沙坦酯/阿折地平相关的文献（医药）

2020-01-01·AAPS PharmSciTech

Chronological Delivery of Antihypertensive Drugs in Bilayered Core-in-Cup Buccoadhesive Tablets: In Vitro and In Vivo Evaluation

Article

作者: Nageeb El-Helaly, Sara ; Rashad, Amira A ; El-Gazayerly, Omaima N ; Abd El Rehim, Randa T

Hypertension shows circadian blood pressure rhythms (day-night pattern) that urge the delivery of antihypertensive drugs at the right time in the desired levels. Thus, a bilayered core-in-cup buccoadhesive tablet was formulated that immediately releases olmesartan, to give a burst effect, and controls azelnidipine release, to prolong its therapeutic effect. The main challenge was the poor bioavailability of azelnidipine due to its poor aqueous solubility and first-pass effect. Hence, liquisolid compact buccoadhesive tablets were prepared to enhance solubility, dissolution profiles, and bypass the oral route. Two factorial designs were conducted to study the type and concentration effect of the mucoadhesive polymers on the dissolution and mucoadhesion of olmesartan and azelnidipine. Characterization studies were conducted regarding drug content, surface pH, water uptake, mucoadhesive strength, in vitro release, and ex vivo permeability. The core-in-cup olmesartan/azelnidipine buccoadhesive tablet showed similar release profile to the statistically optimized formulae of each drug. In vitro dissolution study showed enhanced release of azelnidipine than the directly compressed tablets, to comply with the regulatory standards of controlled release systems. In vivo pharmacokinetic study of olmesartan and azelnidipine conducted on human volunteers against Rezaltas® 10/8 mg tablet showed percentage relative bioavailability of 106.12 and 470.82%, respectively. Graphical Abstract.

100 项与奥美沙坦酯/阿折地平相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	C09D	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
高血压	日本	Daiichi Sankyo Co., Ltd.	2010-01-20

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ISC2020	N/A	卒中后疲劳	36	Olmesartan/Azelnidipine combination	(衊鏇壓鹹鹹鹽觸鹽壓鏇) = 蓋鹽糧窪範餘糧鏇壓鏇齋鏇選襯夢選襯觸鹽餘 (觸蓋鹹淵襯積餘簾網鬱 )	-	2020-02-01
				High-dose olmesartan	(衊鏇壓鹹鹹鹽觸鹽壓鏇) = 齋鹹醖積鬱顧糧夢襯製齋鏇選襯夢選襯觸鹽餘 (觸蓋鹹淵襯積餘簾網鬱 )