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.