IngentaConnect Oral Sumatriptan Pharmacokinetics in the Migraine State

Authors: Sramek J.J.¹; Hussey E.K.²; Clements B.²; Cutler N.R.¹

Source: Clinical Drug Investigation, Volume 17, Number 2, 1 February 1999 , pp. 137-144(8)

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.

Keywords: Sumatriptan, pharmacokinetics; Oral; Migraine; Clinical-pharmacokinetics

Document Type: Original article

Affiliations: 1: California Clinical Trials, Beverly Hills, California, USA 2: Glaxo Research Institute, Research Triangle Park, North Carolina, USA

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