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: <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. Conclusion: Sumatriptan and naproxen pharmacokinetics were not dissimilar between adolescent migraineurs and healthy adults.