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

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 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: