An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R208 (Candesartan cilexetil 8mg/Rosuvastatin 10mg), a fixed dose combination compared with coadministration of separate constituents in healthy adult volunteers

开始日期2016-03-01

申办/合作机构

Alvogen Korea Co., Ltd.

NCT02770261 / Completed临床3期

A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy in Patients With Hypertension and Primary Hypercholesterolemia.

The purpose of this study is to determine superiority of DP-R208 compare to each monotherapy in patient with hypertension and primary hypercholesterolemia.

开始日期2015-12-01

申办/合作机构

Alvogen Korea Co., Ltd.

NCT02707224 / Completed临床1期

A Randomized, Single-dose, Open, Crossover Clinical Trial to Compare the Pharmacokinetics of DP-R208 (Candesartan Cilexetil and Rosuvastatin Calcium Fixed Dose Combinations) in Comparison to Each Component Administered Alone in Healthy Male Volunteers

A randomized, single-dose, open, crossover clinical trial to compare the pharmacokinetics of DP-R208 (Candesartan cilexetil and Rosuvastatin calcium fixed dose combinations) in comparison to each component administered alone in healthy male volunteers

开始日期2015-01-01

申办/合作机构

Alvogen Korea Co., Ltd.

100 项与坎地沙坦酯/瑞舒伐他汀钙相关的临床结果

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100 项与坎地沙坦酯/瑞舒伐他汀钙相关的转化医学

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100 项与坎地沙坦酯/瑞舒伐他汀钙相关的专利（医药）

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项与坎地沙坦酯/瑞舒伐他汀钙相关的文献（医药）

2017-03-01·Int. Journal of Clinical Pharmacology and Therapeutics4区 · 医学

Pharmacokinetic and bioequivalence study comparing a candesartan cilexetil/rosuvastatin calcium fixed-dose combination with the concomitant administration of candesartan cilexetil and rosuvastatin calcium in healthy Korean subjects

4区 · 医学

Article

作者: Lee, Back-Hwan ; Park, Dan-Bee ; Park, Cheol-Won ; Jang, Kyungho ; Lee, Jae-Won ; Jeon, Ji-Young ; Kim, Min-Gul

CONTEXTA fixed-dose combination (FDC) of candesartan and rosuvastatin was recently developed for the treatment of cardiovascular disease and expected to enhance patient compliance.OBJECTIVEThis study was performed to compare the single-dose pharmacokinetic properties and tolerability of DP-R208 (candesartan and rosuvastatin FDC) to those of each component administered alone in healthy Korean male volunteers.MATERIALS AND METHODSA total of 40 healthy Korean volunteers were enrolled in this randomized, open-label, single-dose, two-treatment, two-way crossover study. During each treatment period, subjects received the test formulation (FDC tablet containing candesartan and rosuvastatin) or reference formulation (co-administration of candesartan and rosuvastatin). Plasma samples were collected pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours post-dose. Safety and tolerability were assessed by the evaluation of adverse events (AEs), physical examinations, laboratory assessments, 12-lead electrocardiograms (ECGs), and vital sign measurements.RESULTSThe 90% confidence intervals (CIs) of the geometric least-square mean ratios of C_max, AUC_last, and AUC_inf were 0.86 - 1.00, 0.92 - 1.04, and 0.92 - 1.03 for candesartan, and 0.88 - 1.06, 0.91 - 1.08, and 0.91 - 1.03 for rosuvastatin, respectively. All of the AEs were mild, and there was no significant difference in the incidence of AEs between the formulations. Furthermore, the pharmacokinetic properties of the test and reference formulations met the regulatory criteria for bioequivalence. Discussion and conclusion: Both formulations were safe and well tolerated, and no significant difference was observed in the safety assessments of the treatments. .

100 项与坎地沙坦酯/瑞舒伐他汀钙相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
高血压	临床3期	韩国	Alvogen Korea Co., Ltd.	2015-12-01
原发性高胆固醇血症	临床3期	韩国	Alvogen Korea Co., Ltd.	2015-12-01

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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


NCT02770261 (Pubmed \| Med Lett Drugs Ther)	临床3期	高血压 \| 高胆固醇血症	394	Candesartan 32 mg/Rosuvastatin 20 mg	(蓋鹹鹹窪齋廠範壓鹽願) = 鏇網築憲製衊鬱衊壓築顧獵鑰顧願鏇鹹鏇淵築 (鹽顧鬱淵鑰願鏇築壓選 )	-	2019-08-01
				Rosuvastatin 20 mg	(蓋鹹鹹窪齋廠範壓鹽願) = 鏇夢繭顧願膚繭構齋糧顧獵鑰顧願鏇鹹鏇淵築 (鹽顧鬱淵鑰願鏇築壓選 )