A Prospective, Multicentre, Randomized, Open Label, Evaluator-Blind, Phase IV Study to Evaluate the Effect on Improvement of Left Ventricular Hypertrophy by the Control of Blood Pressure in Hypertension Patients With Aortic Valve Disease

To compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and evaluate an influence of blood pressure regulation on improvement of left ventricular hypertrophy and its safety

开始日期2018-10-18

申办/合作机构

Hanmi Pharmaceutical Co., Ltd.

NCT04252872 / Completed临床1期

A Randomized, Open-label, Oral Single Dose, Two-way Crossover Clinical Trial to Compare the Pharmacokinetics and Safety/Tolerability After Administration of HCP1401 and Co-administration of HCP0605 and HGP1405 in Healthy Male Volunteers

A randomized, open-label, oral single dose, two-way crossover clinical trial to compare the pharmacokinetics and safety/tolerability after administration of HCP1401 and co-administration of HCP0605 and HGP1405 in healthy male volunteers

开始日期2015-08-01

申办/合作机构

Hanmi Pharmaceutical Co., Ltd.

NCT02916602 / Completed临床3期

A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605

A phase 3 study to evaluate efficacy and safety of HCP1401

开始日期2015-04-01

申办/合作机构

Hanmi Pharmaceutical Co., Ltd.

100 项与 Amlodipine/chlortalidone/losartan 相关的临床结果

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100 项与 Amlodipine/chlortalidone/losartan 相关的转化医学

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100 项与 Amlodipine/chlortalidone/losartan 相关的专利（医药）

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项与 Amlodipine/chlortalidone/losartan 相关的文献（医药）

2022-01-01·Clinical Pharmacology in Drug Development

Pharmacokinetics of a Fixed‐Dose Combination of Amlodipine/Losartan and Chlorthalidone Compared to Concurrent Administration of the Separate Components

Article

作者: Choi, Yewon ; Chung, Jae‐Yong ; Jung, Jina ; Moon, Seol Ju ; Jeon, Inseung ; Park, Sang‐In ; Yu, Kyung‐Sang

AbstractHypertension is more effectively treated with coadministration of 2 or more antihypertensive drugs than with high‐dose monotherapy. Therefore, calcium channel blockers, angiotensin II receptor blockers, and thiazides are coadministered to treat hypertension. The objective of this study was to compare the pharmacokinetic (PK) profiles of HCP1401, a fixed‐dose combination of amlodipine 5 mg, losartan 100 mg, and chlorthalidone 25 mg, with the separate components (loose combination) of amlodipine/losartan 5/100 mg and chlorthalidone 25 mg. A randomized, open‐label, single‐dose, 2‐way crossover study was conducted. Blood samples for amlodipine and chlorthalidone were collected for up to 144 hours after dosing, whereas those for losartan were collected up to 48 hours after dosing. The PK parameters of these drugs were calculated using a noncompartmental method. Sixty subjects completed the study. The geometric mean ratios and 90% confidence intervals of maximum plasma concentration and area under the concentration–time curve to the last measurable point for amlodipine, losartan, and chlorthalidone were within the conventional bioequivalence range of 0.80 to 1.25. There were no clinically significant changes in safety assessments, and the treatments were well tolerated. The PK characteristics and tolerability profiles of a single oral FDC of amlodipine, losartan, and chlorthalidone were equivalent to those of individual tablets in a loose combination.

100 项与 Amlodipine/chlortalidone/losartan 相关的药物交易

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