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Pharmacokinetics of single and multiple oral doses of valsartan/amlodipine (80/5 mg) in healthy Chinese subjects
Duan, Jingli1; Chen, Jin2; Yin, Qi3; Karan, Rajesh4; Meiser, Karin5; Smith, Harold Tom2; Sunkara, Gangadhar2
关键词Pharmacokinetics Valsartan Amlodipine Antihypertensive Fixed-dose Combination Chinese
刊名INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
2012
DOI10.5414/CP201601
50期:1页:33-43
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Pharmacology & Pharmacy
研究领域[WOS]Pharmacology & Pharmacy
关键词[WOS]BLOOD-PRESSURE ; ADULT PATIENTS ; AMLODIPINE ; VALSARTAN ; HYPERTENSION ; COMBINATION ; TOLERABILITY ; MONOTHERAPY ; EFFICACY
英文摘要

Objective: The efficacy and safety of valsartan/amlodipine combination have been demonstrated for the treatment of hypertension. In China, where the prevalence of hypertension is increasing the pharmacokinetic study of valsartan, amlodipine assumes significance. The aim of this study was to characterize the pharmacokinetics (PK) of valsartan and amlodipine following single- and multiple-dose oral administrations of valsartan/amlodipine 80/5 mg fixed-dose combination in healthy Chinese subjects. Materials and methods: This was an open-label, two-period (single-dose treatment followed by a multiple-dose (once-daily for 9 days), with a 7-day inter-treatment washout period) study conducted in 18 subjects. Serial blood samples were collected at pre-defined time points, and the plasma concentrations of valsartan and amlodipine were measured using LC-MS/MS. Safety was evaluated after single- and multiple-dose drug administration. Results: Following the single-dose oral administration of valsartan/amlodipine 80/5 mg, valsartan and amlodipine plasma concentrations reached peak levels at median t(max) of 3 and 6 h, respectively. These concentrations declined thereafter, with mean elimination half-lives of 7.7 h (single dose) and 8.6 h (multiple dose) for valsartan, and 47 h (single dose) and 45 h (multiple dose) for amlodipine. After a 9-day multiple-dose treatment (at steady state), accumulation of valsartan and amlodipine was consistent with their half-lives. The single- and multiple-dose administration of valsartan/amlodipine 80/5 mg was associated with asymptomatic hypotension, consistent with the pharmacological activity of the combination of these two blood pressure-lowering drugs when co-administered in healthy subjects. Conclusion: The PK of valsartan and amlodipine are linear following oral administration of valsartan/amlodipine fixed-dose combination.

语种英语
WOS记录号WOS:000299982700005
资助机构Novartis Pharma AG, Basel, Switzerland
引用统计
被引频次:2[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/54872
专题北京大学第三临床医学院_药剂科
作者单位1.Novartis Inst Biomed Res Inc, Translat Sci, E Hanover, NJ USA
2.Novartis Pharmaceut, Beijing, Peoples R China
3.Novartis Healthcare Pvt Ltd, Hyderabad, Andhra Pradesh, India
4.Peking Univ Third Hosp, Dept Pharm, Beijing 100871, Peoples R China
5.Novartis Pharma AG, Translat Sci Biostat, Basel, Switzerland
推荐引用方式
GB/T 7714
Duan, Jingli,Chen, Jin,Yin, Qi,et al. Pharmacokinetics of single and multiple oral doses of valsartan/amlodipine (80/5 mg) in healthy Chinese subjects[J]. INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS,2012,50(1):33-43.
APA Duan, Jingli.,Chen, Jin.,Yin, Qi.,Karan, Rajesh.,Meiser, Karin.,...&Sunkara, Gangadhar.(2012).Pharmacokinetics of single and multiple oral doses of valsartan/amlodipine (80/5 mg) in healthy Chinese subjects.INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS,50(1),33-43.
MLA Duan, Jingli,et al."Pharmacokinetics of single and multiple oral doses of valsartan/amlodipine (80/5 mg) in healthy Chinese subjects".INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS 50.1(2012):33-43.
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