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学科主题: 临床医学
题名:
Evaluation of the pharmacokinetics and safety of single and multiple ceftaroline fosamil infusions in healthy Chinese and Western subjects
作者: 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
发表日期: 2015-08-01
DOI: 10.5414/CP202343
卷: 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
项目资助者: AstraZeneca
WOS记录号: WOS:000362303300009
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/62910
Appears in Collections:北京大学第三临床医学院_期刊论文

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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

Recommended Citation:
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.
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