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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Single- and multiple-dose pharmacokinetic comparison of a sustained-release tablet and conventional tablets of naproxen in healthy volunteers.
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Single- and multiple-dose pharmacokinetic comparison of a sustained-release tablet and conventional tablets of naproxen in healthy volunteers.

机译：萘普生缓释片剂和常规片剂在健康志愿者中的单剂量和多剂量药代动力学比较。

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摘要

The pharmacokinetics of a new sustained-release tablet of naproxen (500 mg once daily) were compared with a conventional tablet (250 mg twice daily) after single- or multiple-dose oral administration in healthy volunteers using an open, randomized two-way crossover experimental design. Naproxen was well absorbed from the sustained-release tablet (approximately 97%) compared with the conventional tablet. Pharmacokinetic data showed that the sustained-release formulation reached significantly delayed mean peak plasma levels (Cmax) in both single- and multiple-dose studies and lower Cmax in a single-dose study than the conventional formulation. However, there were no statistically significant differences in other pharmacokinetic parameters, including area under the concentration-time curve (AUC), elimination half-life (t1/2), and elimination rate constant (Ke), in either single- or multiple-dose studies between the two treatments. In addition, there were no significant differences between formulations in Cmax, minimum plasma concentration (Cmin), and fluctuation index in the multiple-dose study.
机译：在健康志愿者中，采用开放，随机的双向转换方法，在健康志愿者中单次或多次口服纳普生新缓释片（每日一次500毫克）与常规片剂（每日两次250毫克）的药代动力学进行比较实验设计。与常规片剂相比，萘普生从缓释片剂中吸收良好（约97％）。药代动力学数据显示，单剂量和多剂量研究中的缓释制剂均达到显着延迟的平均峰值血浆水平（Cmax），而单剂量研究中的Cmax低于常规制剂。但是，在单药或多药中，其他药代动力学参数在统计学上无显着差异，包括浓度-时间曲线下面积（AUC），消除半衰期（t1 / 2）和消除速率常数（Ke）。两种治疗之间的剂量研究。此外，在多剂量研究中，制剂的Cmax，最低血浆浓度（Cmin）和波动指数之间没有显着差异。

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