国产左乙拉西坦片的人体生物等效性试验

发布时间：2018-03-06 01:21

  本文选题：左乙拉西坦　切入点：空腹　出处：《中国新药杂志》2016年19期 　论文类型：期刊论文

【摘要】：目的:研究在空腹和餐后条件下国产左乙拉西坦片的生物等效性,并探讨餐后给药试验的意义和样本量对试验结果的影响。方法:分别进行空腹和餐后单次给药的二交叉生物等效性试验,22名健康男性受试者口服国产左乙拉西坦片(受试制剂)或进口左乙拉西坦片(参比制剂)0.5 g,液相色谱-串联质谱联用法测定血浆中左乙拉西坦的浓度。采用Win Nonlin 6.4软件,非房室模型法计算药动学参数,药动学参数AUC和Cmax对数转换后,以90%置信区间(90%CI)法进行生物等效性评价。结果:在空腹和餐后条件下,健康男性受试者口服国产和进口左乙拉西坦片后左拉西坦的AUC0~t,AUC0~∞和Cmax几何均数比值(GMR)的90%CI均在80.00%~125.00%的范围内。与空腹给药相比,餐后给药后Tmax延长,Cmax降低,而AUC和t1/2没有差异。结论:在空腹和餐后条件下国产和进口左乙拉西坦片具有生物等效性;左乙拉西坦片的生物等效性试验可仅进行空腹试验,且12例样本量即可。
[Abstract]:Objective: to study the bioequivalence of domestic levoethylacetam tablets under fasting and postprandial conditions. To explore the significance of postprandial drug administration test and the effect of sample size on the results. Methods: 22 healthy male subjects were given domestic levoethylacetam orally in the two-cross bioequivalence test of fasting and single postprandial administration. The concentration of levoethylacetam in plasma was determined by liquid chromatography-tandem mass spectrometry (LC-MS) or imported levoethylacetam tablets (reference preparation 0.5 g). Win Nonlin 6.4 software was used to determine the concentration of levoethoxetam in plasma. The pharmacokinetic parameters were calculated by non-atrioventricular model method. After logarithmic conversion of pharmacokinetic parameters AUC and Cmax, bioequivalence was evaluated with the 90% confidence interval 90 CI method. Results: under fasting and postprandial conditions, The 90CI of domestic and imported levoxetam AUC0 ~ 鈭，

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