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学科主题: 临床医学
题名:
Pharmacokinetics of single and multiple oral doses of valsartan/amlodipine (80/5 mg) in healthy Chinese subjects
作者: 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
发表日期: 2012
DOI: 10.5414/CP201601
卷: 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
项目资助者: Novartis Pharma AG, Basel, Switzerland
WOS记录号: WOS:000299982700005
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/54872
Appears in Collections:北京大学第三临床医学院_药剂科_期刊论文

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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

Recommended Citation:
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.
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