Pharmacokinetics, Safety, and Tolerability Following the Administration of a Single Dose of a Combination Tablet Containing Sumatriptan and Naproxen Sodium in Adolescent Patients With Migraine and in Healthy Adult Volunteers

Pharmacokinetics, Safety, and Tolerability Following the Administration of a Single Dose of a Combination Tablet Containing Sumatriptan and Naproxen Sodium in Adolescent Patients With Migraine and in Healthy Adult Volunteers
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DOI:
10.1177/2160763x12447302
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发表时间:
2012-07-01
影响因子:
2
通讯作者:
Chen, Chao
Chen, Chao
中科院分区:
医学4区
文献类型:
--
作者:
Berges, Alienor;Robertson, Jonathan;Chen, Chao

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目的:比较舒马曲坦和萘普生在青春期偏头痛患者和健康成人中的药代动力学。设计:这是一项开放标签、随机、平行的分组研究。青春期偏头痛患者(12-17岁)和健康成人接受1剂舒马曲坦/萘普生:10 mg/60 mg、30 mg/180 mg或85 mg/500 mg。进行了药代动力学和安全性评价。结果:舒马曲坦快速达峰时间(中位数t(Max):青少年0.8~1.5小时,成人0.5~2.0小时),消除迅速(几何平均t(1/2):
Objective: The objective was to compare the pharmacokinetics of sumatriptan and naproxen in adolescent migraineurs and healthy adults after administration of sumatriptan/naproxen sodium combination tablets. Design: The design was an open-label, randomized, parallel group study. Adolescent migraineurs (12-17 years) and healthy adults received 1 dose of sumatriptan/naproxen: 10 mg/60 mg, 30 mg/180 mg, or 85 mg/500 mg. Pharmacokinetic and safety assessments were conducted. Results: Sumatriptan achieved C-max rapidly (median t(max) : 0.8-1.5 hours for adolescents, 0.5-2.0 hours for adults); elimination was also rapid (geometric mean t(1/2) :