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《Central South Pharmacy》 2011-09
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Pharmacokinetics of oxiracetam for injection in Chinese healthy volunteers

ZHU Rong-hua1,WAN Shun2,YAN Miao1,HU Jin-cheng2,WANG Feng1,PENG Wen-xing1,TAN Qin-you1,DAI Li-bo1,ZHENG Qiao-ling1,LI Huan-de1(1.Clinical Pharmacy Research Institute,Second Xiangya Hospital,Central South University,Changsha 410011;2.Hunan Jianlang Pharmaceutical Co.,Ltd,Yueyang Hunan 414000)  
Objective To determine the pharmacokinetic characteristics of oxiracetam for injection in Chinese healthy volunteers.Methods A single intravenous dose of 2,4 or 8 g oxiracetam for injection was given to 10 healthy volunteers in an open randomized design.The plasma concentrations of oxiracetam were determined by HPLC-MS/MS.Results The main pharmacokinetic parameters of 2,4 and 8 g oxiracetam for injection were as follows: Cmax was(98.79±19.25),(227.83±36.80),and(361.53±70.59)μg·mL-1;AUC0-24 was(332.9±50.2),(751.9±114.7),and(1311.7±152.3)μg·h·mL-1;AUC0-∞ was(346.0±50.8),(784.3±119.6),and(1 380.7±156.9) μg·h·mL-1.Cmax,AUC0-24,and AUC0-∞ had highly positive relation with the dosage of oxiracetam(r2 was 0.921 7,0.925 5 and 0.823 9 respectively).T1/2 was(6.96±0.60),(6.99±0.75),and(7.37±0.75)h;V was(59.4±12.2),(52.8±11.3),and(62.5±10.0) L;CL was(5.90±0.90),(5.22±0.88),and(5.86±0.65) L·h-1;and MRT was(5.42±0.60),(5.66±0.49),and(6.16±0.69) h.Conclusion There is linear pharmacokinetics of oxiracetam between 2 and 8 g single intravenous doses in healthy subjects.Oxiracetam is well tolerated and no adverse reaction is observed during the trial.
【CateGory Index】: R969.1
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