Clinical Drug Investigation

, Volume 17, Issue 2, pp 137–144

Oral Sumatriptan Pharmacokinetics in the Migraine State

  • John J. Sramek
  • Elizabeth K. Hussey
  • Bill Clements
  • Neal R. Cutler
Clinical Pharmacokinetics

Abstract

Objective: This double-blind, parallel, multicentre study investigated the effect of migraine on absorption of oral sumatriptan (25, 50 and 100mg) compared with placebo.

Design: Patients received sumatriptan or placebo in the clinic during an acute migraine and at least 7 days later, when pain-free. Pharmacokinetic and efficacy (n = 192) and safety (n = 259) parameters were assessed for 4 hours after administration of study medication.

Results: Absorption of sumatriptan from 50 and 100mg tablets was not significantly different between the migraine and pain-free periods. There was however a statistically significant decrease (approximately 23%) and delay (35 minutes) in absorption of sumatriptan from the 25mg tablet during a migraine compared with the pain-free period. Sumatriptan pharmacokinetics exhibited dose proportionality during the migraine and pain-free periods. All doses of sumatriptan were significantly superior to placebo in reducing headache pain. Adverse events were comparable among the sumatriptan groups and placebo group.

Conclusions: Absorption of sumatriptan, administered at therapeutic doses, was not statistically significantly impaired during migraine versus the pain-free state. These data suggest that coadministration of drugs that improve the absorption of sumatriptan is not necessary during sumatriptan treatment.

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Copyright information

© Adis International Limited 1999

Authors and Affiliations

  • John J. Sramek
    • 1
  • Elizabeth K. Hussey
    • 2
  • Bill Clements
    • 2
  • Neal R. Cutler
    • 1
  1. 1.California Clinical TrialsBeverly HillsUSA
  2. 2.Glaxo Research InstituteResearch Triangle ParkUSA

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