Rizatriptan, a novel 5-HT1B/1D agonist for migraine: single- and multiple-dose tolerability and pharmacokinetics in healthy subjects

J Clin Pharmacol. 2000 Jan;40(1):74-83. doi: 10.1177/00912700022008595.

Abstract

Rizatriptan is a novel 5-HT1D/1B agonist for relief of migraine headache. The pharmacokinetics, metabolite profiles, and tolerability of rizatriptan were examined in a multiple-dose study in healthy subjects. Rizatriptan (N = 24) (or placebo, N = 12) was administered as a single 10 mg dose, followed 48 hours later by administration of one 10 mg dose every 2 hours for three doses on 4 consecutive days, corresponding to the maximum daily dose for a migraine attack. The AUC of rizatriptan and its active N-monodesmethyl metabolite after three 10 mg doses was approximately threefold greater than the plasma concentrations following a single 10 mg dose. Metabolite profiles were similar after single and multiple doses. Adverse events during rizatriptan were mild and transient; similar events occurred during placebo, with a somewhat reduced incidence. Diastolic blood pressure tended to increase compared with placebo (approximately 5 mmHg), particularly on the first multiple-dose day (p < .01 vs. placebo). In conclusion, rizatriptan is well tolerated by healthy subjects during multiple-dose administration, with no unexpected accumulation of drug in plasma.

Publication types

  • Clinical Trial
  • Comparative Study

MeSH terms

  • Adult
  • Blood Pressure / drug effects
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Placebos
  • Serotonin Receptor Agonists / administration & dosage
  • Serotonin Receptor Agonists / adverse effects*
  • Serotonin Receptor Agonists / pharmacokinetics*
  • Time Factors
  • Triazoles / administration & dosage
  • Triazoles / adverse effects*
  • Triazoles / pharmacokinetics*
  • Tryptamines

Substances

  • Placebos
  • Serotonin Receptor Agonists
  • Triazoles
  • Tryptamines
  • rizatriptan