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学科主题临床医学
Pharmacokinetics, Pharmacodynamics, Tolerability and Safety of Single Doses of Bivalirudin in Healthy Chinese Subjects
Zhang, Dongmei1; Wang, Zining1; Zhao, Xia1; Lu, Wei2; Gu, Jingkai3; Cui, Yimin1
关键词bivalirudin anticoagulant healthy Chinese subject pharmacokinetics pharmacodynamics
刊名BIOLOGICAL & PHARMACEUTICAL BULLETIN
2011-12-01
34期:12页:1841-1848
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Pharmacology & Pharmacy
资助者Shenzhen Main Luck Pharmaceuticals, Inc. ; Shenzhen Main Luck Pharmaceuticals, Inc.
研究领域[WOS]Pharmacology & Pharmacy
关键词[WOS]PERCUTANEOUS CORONARY INTERVENTION ; UNFRACTIONATED HEPARIN ; HUMANS ; ABCB1
英文摘要

The objectives of the present study were to assess pharmacokinetics, pharmacodynamics, tolerability and safety of intravenous administration of bivalirudin, a direct thrombin inhibitor, in healthy Chinese subjects. 48 subjects were equally divided into 4 groups (0.5 mg/kg, 0.75 mg/kg, 1.05 mg/kg intravenous bolus, and 0.75 mg/kg intravenous bolus followed by an infusion of 1.75 mg/kg per hour for 4h) by a randomized, single-blind and placebo-controlled (bivalirudin groups: n = 9/group; placebo groups: a = 3/group) design. The safety observations showed that bivalirudin was well tolerated in the studied dose range, all adverse events were mild in severity. The half-life of bivalirudin was approximately 0.57 h (34 min), exposure increased in a dose-dependent manner. In group receiving a 0.75 mg/kg intravenous bolus followed by 1.75 mg/kg per hour infusion for 4 h, bivalirudin concentrations remained at 5000-5500 mu g/l within the 4 h infusion period, which was similar to the reported data of Caucasian patients and can provide the desired anticoagulant effects. There was a strong correlation between bivalirudin concentration and anticoagulant effect. A Sigmoid model was used to fit the pharmacodynamic parameters activated clotting time (ACT), activated partial thromboplastin time (APTT) and prothrombin time (PT) and bivalirudin concentrations. The findings of this study suggest that the same dosing regimens of bivalirudin may be administered to Chinese and Caucasian patients. Ongoing and future studies in large populations may add further information.

语种英语
资助者Shenzhen Main Luck Pharmaceuticals, Inc. ; Shenzhen Main Luck Pharmaceuticals, Inc.
WOS记录号WOS:000297399200013
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/400002259/60421
专题北京大学第一临床医学院_药剂科
作者单位1.Peking Univ, Hosp 1, Base Clin Trial, Dept Pharm, Beijing 100034, Peoples R China
2.Peking Univ, State Key Lab Nat & Biomimet Drugs, Beijing 100191, Peoples R China
3.Jilin Univ, Res Ctr Drug Metab, Changchun 130023, Peoples R China
推荐引用方式
GB/T 7714
Zhang, Dongmei,Wang, Zining,Zhao, Xia,et al. Pharmacokinetics, Pharmacodynamics, Tolerability and Safety of Single Doses of Bivalirudin in Healthy Chinese Subjects[J]. BIOLOGICAL & PHARMACEUTICAL BULLETIN,2011,34(12):1841-1848.
APA Zhang, Dongmei,Wang, Zining,Zhao, Xia,Lu, Wei,Gu, Jingkai,&Cui, Yimin.(2011).Pharmacokinetics, Pharmacodynamics, Tolerability and Safety of Single Doses of Bivalirudin in Healthy Chinese Subjects.BIOLOGICAL & PHARMACEUTICAL BULLETIN,34(12),1841-1848.
MLA Zhang, Dongmei,et al."Pharmacokinetics, Pharmacodynamics, Tolerability and Safety of Single Doses of Bivalirudin in Healthy Chinese Subjects".BIOLOGICAL & PHARMACEUTICAL BULLETIN 34.12(2011):1841-1848.
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