A three-way crossover study in 27 human volunteers was conducted to characterize the pharmacokinetics and to assess the dose proportionality of 100 mg, 200 mg and 300 mg strengths of a novel once-a-day tramadol controlled-release tablet (Tramadol Contramid OAD) following single-dose administration. Serial blood samples were collected at predefined timepoints over a 48 h period and racemic tramadol and O-desmethyltramadol concentrations in plasma were determined using a validated LC-MS/MS method. Pharmacokinetic parameters were derived using noncompartmental methods. Following dose normalization and logarithmic transformation of concentration-dependent parameters, the results were compared using analysis of variance (ANOVA). The residual variability thereby obtained was used to construct 90% classical confidence intervals. The two one-sided tests procedure was used for all pairwise comparisons. Dose proportionality was concluded since the 90% CI for the ratio of geometric means was included in the acceptance range of 0.80-1.25 for all comparisons.

译文

在27名人类志愿者中进行了一项三向交叉研究,以表征药代动力学并评估100 mg,200 mg和300 mg的剂量比例。单剂量给药后的新型曲马多控释片 (曲马多对照OAD) 的强度。在48小时内的预定时间点收集连续血液样本,并使用经过验证的lc-ms/MS方法测定血浆中外消旋曲马多和O-去甲基曲马多的浓度。药代动力学参数是使用非隔室方法得出的。在剂量归一化和浓度相关参数的对数转换之后,使用方差分析 (ANOVA) 比较结果。由此获得的残差变异性用于构建90% 经典置信区间。所有成对比较均使用两个单侧测试程序。由于几何平均值比的90% CI被包括在所有比较的0.80-1.25的接受范围内,因此得出了剂量比例。

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