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位人类志愿者中进行了三项交叉研究,以表征药代动力学并评估新型每日一次曲马多控释片剂(曲马多Contramid OAD)的100 mg,200 mg和300 mg强度的剂量比例)单次给药后。在48小时内的预定时间点采集系列血样,并使用经过验证的LC-MS / MS方法测定血浆中的外消旋曲马多和O-去甲基曲马多浓度。使用非房室方法得出药代动力学参数。剂量归一化和浓度依赖性参数的对数转换后,使用方差分析(ANOVA)比较结果。由此获得的残余变异性用于构建90%的经典置信区间。所有的成对比较均使用两个单面测试程序。由于所有比较的几何均数比率的90%CI都在0.80-1.25的接受范围内,因此得出剂量比例。

+1
+2
100研值 100研值 ¥99课程
检索文献一次
下载文献一次

去下载>

成功解锁2个技能,为你点赞

《SCI写作十大必备语法》
解决你的SCI语法难题!

技能熟练度+1

视频课《玩转文献检索》
让你成为检索达人!

恭喜完成新手挑战

手机微信扫一扫,添加好友领取

免费领《Endnote文献管理工具+教程》

微信扫码, 免费领取

手机登录

获取验证码
登录