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KMID : 0369820040340030215
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Jorunal of Korean Pharmaceutical Sciences
2004 Volume.34 No. 3 p.215 ~ p.222
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Bioequivalence of Neuracetam Tablet to Neuromed Tablet (Oxiracetam 800 mg)
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최성업/Choi SU
김종석/윤미경/김정일/박석/한상범/이재휘/최영욱/Kim JS/Yoon MK/Kim JI/Park S/Han SB/Lee JH/Choi YW
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Abstract
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The purpose of the present study was designed to evaluate the bioequivalence of two oxiracetam tablets, Neuromed tablet (Korea Drug Co., reference drug) and Neuracetam tablet (Sam Jin Pharmaceutical Co., test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Release of oxiracetam from the tablet in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty-four healthy volunteers, 23.7±2.4 year in age and 68.9±6.2 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was performed. After oral administration of a tablet containing 800 mg of oxiracetam, blood samples were taken at predetermined time intervals and concentrations of oxiracetam in plasma were determined using HPLC-MS-MS. The dissolution profiles of two formulations were very similar at all dissolution media. In addition, pharmacokinetic parameters such as AUCt, Cmax and Tmax were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUCt and Cmax untransformed Tmax. The results showed that the differences between two formulations based on the reference drug were 0.42%, 0.45% and -12.58% for AUCt, Cmax and Tmax, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log0.94∼log1.06 and log0.90∼log1.07 for AUCt, and Cmax, respectively), indicating that Neuracetam tablet is bioequivalent to Neuromed tablet. The major pharmacokinetic parameters, AUCt, and Cmax met the criteria set by KFDA for bioequivalence indicating that Neuracetam tablet is bioequivalent to Neuromed tablet.
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KEYWORD
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Oxiracetam, Neuromed, Neuracetam, Bioequivalence, HPLC-MS-MS
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