IR@PKUHSC  > 北京大学第三临床医学院
学科主题临床医学
Evaluation of the pharmacokinetics and safety of single and multiple ceftaroline fosamil infusions in healthy Chinese and Western subjects
Yang, Li1; Sunzel, Maria2; Xu, Peng3; Edeki, Timi2; Wilson, David4; Li, Jianguo5; Li, Haiyan1
关键词ceftaroline fosamil ceftaroline pharmacokinetics safety
刊名INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
2015-08-01
DOI10.5414/CP202343
53期:8页:681-691
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]SKIN-STRUCTURE INFECTIONS ; DOUBLE-BLIND ; TOLERABILITY ; ANTIBIOTICS ; POPULATION ; PNEUMONIA
英文摘要

Objectives: Two phase I studies in healthy Chinese (NCT01458743) and Western (NCT01612507) subjects evaluated the pharmacokinetics (PK) and safety of single and multiple ceftaroline fosamil 600 mg infusions administered every 8 or 12 hours (q8h or q12h). Methods: Each study enrolled subjects sequentially into 1 of 2 cohorts (cohort 1: 60-minute infusions; cohort 2: 120-minute infusions). All subjects in the Chinese (n = 26) study received open-label ceftaroline fosamil; in the Western study, subjects (n = 41) in each cohort were randomized 3 : 1 to ceftaroline fosamil or placebo infusions. Single infusions were administered on days 1 and 8. On days 2 7 (3 7 for Chinese study, cohort 1) subjects received q12h or q8h infusions. Plasma and urine were collected on days 1 and 8 for PK analysis. Results: Ceftaroline PK was linear and time-independent following single and multiple doses of ceftaroline fosamil. The magnitude and timing of peak plasma concentrations of ceftaroline (active metabolite), ceftaroline fosamil (prodrug), and ceftaroline M-1 (inactive metabolite) varied according to the ceftaroline fosamil dosing schedule (q12h or q8h) and infusion duration (60 minutes or 120 minutes), but overall plasma ceftaroline exposures within the respective dosing intervals were broadly similar across cohorts. The most frequent adverse events were rash/drug eruption, most of which were of mild-moderate intensity and considered related to treatment. Conclusions: Ceftaroline PK was broadly similar in healthy Chinese and Western subjects receiving equivalent dose regimens. The tolerability profile of ceftaroline fosamil in Chinese and Western subjects was consistent with previous clinical trials.

语种英语
WOS记录号WOS:000362303300009
资助机构AstraZeneca
引用统计
被引频次:4[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/400002259/62910
专题北京大学第三临床医学院
作者单位1.AstraZeneca China, Shanghai, Peoples R China
2.AstraZeneca, Alderley Pk, Cheshire, England
3.AstraZeneca, Waltham, MA USA
4.Peking Univ, Hosp 3, Beijing 100871, Peoples R China
5.AstraZeneca, Wilmington, DE USA
推荐引用方式
GB/T 7714
Yang, Li,Sunzel, Maria,Xu, Peng,et al. Evaluation of the pharmacokinetics and safety of single and multiple ceftaroline fosamil infusions in healthy Chinese and Western subjects[J]. INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS,2015,53(8):681-691.
APA Yang, Li.,Sunzel, Maria.,Xu, Peng.,Edeki, Timi.,Wilson, David.,...&Li, Haiyan.(2015).Evaluation of the pharmacokinetics and safety of single and multiple ceftaroline fosamil infusions in healthy Chinese and Western subjects.INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS,53(8),681-691.
MLA Yang, Li,et al."Evaluation of the pharmacokinetics and safety of single and multiple ceftaroline fosamil infusions in healthy Chinese and Western subjects".INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS 53.8(2015):681-691.
条目包含的文件
条目无相关文件。
个性服务
推荐该条目
保存到收藏夹
查看访问统计
导出为Endnote文件
谷歌学术
谷歌学术中相似的文章
[Yang, Li]的文章
[Sunzel, Maria]的文章
[Xu, Peng]的文章
百度学术
百度学术中相似的文章
[Yang, Li]的文章
[Sunzel, Maria]的文章
[Xu, Peng]的文章
必应学术
必应学术中相似的文章
[Yang, Li]的文章
[Sunzel, Maria]的文章
[Xu, Peng]的文章
相关权益政策
暂无数据
收藏/分享
所有评论 (0)
暂无评论
 

除非特别说明,本系统中所有内容都受版权保护,并保留所有权利。