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首页> 外文期刊>International journal of clinical pharmacology and therapeutics >Pharmacokinetics of rizatriptan in healthy elderly subjects.
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Pharmacokinetics of rizatriptan in healthy elderly subjects.

机译：利扎曲普坦在健康老年受试者中的药代动力学。

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OBJECTIVE: Rizatriptan is a serotonin 5-HT1B/1D receptor agonist for acute treatment of migraine. Its pharmacokinetics were assessed in healthy elderly males and females receiving a single 10 mg tablet oral dose. The pharmacokinetic data (AUC(0-infinity) and Cmax) for the elderly in this study were compared with historical data from previous studies for healthy young adults (n = 65). METHODS: In a double-blind, parallel, placebo-controlled study, healthy elderly female and male subjects aged 65 or older (n = 8 each) received a single oral dose of 10 mg rizatriptan. Plasma and urine concentrations of drug were determined by HPLC with tandem mass spectrometry detection at several collection time points or intervals starting at predose and postdose over 24 h. RESULTS: In elderly subjects, the geometric mean values for AUC(0-infinity) and Cmax were 77.7 ng/h/ml and 21.9 ng/ml; the average values for tmax, half-life (t 1/2), renal clearance (Clr), and percent urinary excretion of dose (Ue) were 1.2 h, 1.8 h, 197 ml/min and 9.3%, respectively. The AUC(0-infinity) and Cmax of rizatriptan were similar in elderly and young subjects. The geometric mean AUC ratio of elderly to young was 0.96 with 90% confidence interval (0.83, 1.11), p > 0.25. The geometric mean Cmax ratio was 0.89 with 90% confidence interval (0.72, 109), p > 0.25. No significant pharmacokinetic differences were observed between elderly males and females. CONCLUSIONS: The plasma pharmacokinetics of rizatriptan appear to be similar in the elderly and young. In the elderly, the pharmacokinetics of rizatriptan do not appear to differ between male and female to a clinically significant extent.
机译：目的：利扎曲普坦是5-羟色胺5-HT1B / 1D受体激动剂，用于急性偏头痛的治疗。在接受单次10毫克片剂口服剂量的健康老年男性和女性中评估了其药代动力学。将本研究中老年人的药代动力学数据（AUC（0-无穷大）和Cmax）与健康年轻人（n = 65）以前的研究历史数据进行了比较。方法：在一项双盲，平行，安慰剂对照研究中，年龄在65岁或以上（每人n = 8）的健康老年女性和男性受试者单次口服口服10 mg利扎曲普坦。药物的血浆和尿液浓度通过HPLC和串联质谱检测在从剂量前和剂量后24小时开始的几个收集时间点或间隔进行测定。结果：在老年受试者中，AUC（0-无穷大）和Cmax的几何平均值分别为77.7 ng / h / ml和21.9 ng / ml。 tmax，半衰期（t 1/2），肾清除率（Clr）和尿液排泄百分数（Ue）的平均值分别为1.2 h，1.8 h，197 ml / min和9.3％。利扎曲普坦的AUC（0-无穷大）和Cmax在老年和青年受试者中相似。老年人与年轻人的几何平均AUC比率为0.96，置信区间为90％（0.83，1.11），p> 0.25。几何平均Cmax比为0.89，置信区间为90％（0.72，109），p> 0.25。老年男性和女性之间没有观察到明显的药代动力学差异。结论：利扎曲普坦的血浆药代动力学在老年人和年轻人中似乎相似。在老年人中，利扎曲普坦的药代动力学在男性和女性之间似乎没有临床上的显着差异。

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