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.

Abstract

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. 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. Sumatriptan achieved Cmax rapidly (median tmax : 0.8-1.5 hours for adolescents, 0.5-2.0 hours for adults); elimination was also rapid (geometric mean t½ : <2 hours for adolescents, 1.9-2.4 hours for adults). Compared with sumatriptan, naproxen was absorbed and eliminated more slowly (median tmax : 1.0-4.0 hours for adolescents, 1.0-3.0 hours for adults; geometric mean t½ : 13.4-16.3 hours for adolescents, 14.3-16.6 hours for adults). Sumatriptan Cmax and AUC were similar for adolescents and adults for the 85 mg/500 mg dose; exposure for the 2 lower doses showed slight differences (not significant). Naproxen Cmax and AUC were comparable between the 2 groups at all doses. Increases in sumatriptan Cmax and AUC were dose proportional; for naproxen, slightly less than proportional. The tablets were generally well tolerated. Sumatriptan and naproxen pharmacokinetics were not dissimilar between adolescent migraineurs and healthy adults.