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Pharmacokinetics of Naratriptan in Adolescent Subjects with a History of Migraine
Author(s) -
Christensen Michael L.,
Eades Shannan K.,
Fuseau Eliane,
Kempsford Rodger D.,
Phelps Stephanie J.,
Hak Lawrence J.
Publication year - 2001
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/00912700122009980
Subject(s) - medicine , pharmacokinetics , migraine , cmax , anesthesia , confidence interval , dosing , blood pressure , adverse effect , oral administration , area under the curve , sumatriptan , pulse rate , agonist , receptor
Naratriptan is a novel 5‐HT 1 agonist developed to treat acute migraine. The study objective was to characterize the pharmacokinetics of oral naratriptan in adolescent migraine patients outside a migraine attack. Subjects received a single 2.5 mg naratriptan tablet. Serial serum samples for naratriptan concentrations were collected over 24 hours. Blood pressure, pulse rate, and 12‐lead ECG were recorded at baseline and at regular intervals after dosing. Seven patients—3 males and 4 females, 12 to 16 years of age—received drug and completed the study. The geometric mean and 95% confidence interval maximum concentration (C max ) was 8.0 ng/mL (5.9–10.7), elimination half‐life (t 1/2 ) was 4.9 hours (4.5‐5.4), area under the concentration‐time curve (AUC) was 74.6 ng•h/mL (56.6–98.2), and apparent total clearance (Cl/F) was 558.8 mL/min (424.3–735.9). The median time to maximal concentration (t max ) was 4 hours, with a range of 1.5 to 4. Blood pressure, pulse rate, and ECG parameters did not change significantly from baseline. No serious adverse events or subject withdrawal after drug administration occurred. Oral naratriptan pharmacokinetic parameters in adolescents were similar to values reported in adults. Naratriptan doses for adolescents older than 12 years of age would be expected to be similar to adult doses.