Pharmacokinetics of sumatriptan nasal spray in adolescents

Michael Christensen, Robin K. Mottern, J. T. Jabbour, Eliane Fuseau

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Sumatriptan is a potent and selective vascular 5-HT 1 receptor agonist effective for the treatment of migraine. In adults, intranasal sumatriptan is well absorbed and tolerated. The authors evaluated the pharmacokinetics and tolerability of a single dose of 20 mg intranasal sumatriptan in healthy adolescent migraineurs ages 12 to 17 years, administered outside of migraine attack. Serum sumatriptan levels were measured by high-performance liquid chromatography (HPLC) with electrochemical detection in serial samples collected over 8 hours. Physical exam, vital signs, clinical laboratory tests, and electrocardiogram measurements were monitored to assess safety and tolerability. A total of 16 subjects (10 males and 6 females) had pharmacokinetic data that could be analyzed, 2 withdrew from the study 30 and 60 minutes after dosing following the loss of venous access for blood sampling, and a bioanalysis failure resulted in loss of data from 3 subjects. Noncompartmental pharmacokinetic parameters (geometric mean and 95% confidence interval) for the remaining 16 subjects were as follows: C max was 13.9 (11.0, 17.6) ng/mL, AUC was 57.3 (47.6, 69.0) ng/mL•h, and t 1/2 was 2.0 (1.8, 2.3) hours. Population pharmacokinetic analysis for all subjects (n = 21) showed that clearance and volume of distribution increase slightly with age and body size, but the changes were minimal and would not warrant dose adjustment: CL/F was 316 L (coefficient of variance [CV] = 25%) and Vd/F was 1070 L (CV = 46%). Sumatriptan was well tolerated with only minor adverse events reported, which all resolved spontaneously. The pharmacokinetic parameters in these adolescent subjects were similar to those previously reported in adults, suggesting that adolescents should be dosed similar to adults.

Original languageEnglish (US)
Pages (from-to)721-726
Number of pages6
JournalJournal of clinical pharmacology
Volume43
Issue number7
DOIs
StatePublished - Jul 1 2003

Fingerprint

Sumatriptan
Nasal Sprays
Pharmacokinetics
Migraine Disorders
Vital Signs
Serotonin Receptors
Body Size
Area Under Curve
Blood Vessels
Electrocardiography
High Pressure Liquid Chromatography
Confidence Intervals
Safety
Serum
Population

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

Cite this

Pharmacokinetics of sumatriptan nasal spray in adolescents. / Christensen, Michael; Mottern, Robin K.; Jabbour, J. T.; Fuseau, Eliane.

In: Journal of clinical pharmacology, Vol. 43, No. 7, 01.07.2003, p. 721-726.

Research output: Contribution to journalArticle

Christensen, Michael ; Mottern, Robin K. ; Jabbour, J. T. ; Fuseau, Eliane. / Pharmacokinetics of sumatriptan nasal spray in adolescents. In: Journal of clinical pharmacology. 2003 ; Vol. 43, No. 7. pp. 721-726.
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