Relative Bioavailability of an Extemporaneous Ondansetron 4-mg Capsule Formulation versus Solution

Y. W.Francis Lam, Martin A. Javors, Nassima Ait-Daoud, John D. Roache, Bankole A. Johnson

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

Study Objective. To compare the relative bioavailability of an extemporaneous ondansetron capsule formulation with that of an identical dose of the commercially available solution formulation. Design. Open-label, randomized, two-way crossover study. Setting. University-affiliated research laboratory. Subjects. Sixteen (eight men, eight women) healthy, nonsmoking volunteers. Intervention. Participants were randomly assigned to receive a 4-mg dose of either the commercially available ondansetron solution or the extemporaneous ondansetron capsule formulation. Blood sampling was performed over 12 hours after dosing. After a washout period of at least 3 days, each participant was switched to the alternate formulation, and blood sampling was repeated. Measurements and Main Results. Ondansetron was well absorbed after administration of both formulations, with the solution achieving a faster rate of drug absorption over the first hour of dosing. After the peak plasma concentration was achieved, the plasma concentration-time curves of both formulations declined at a similar steady rate. There were no significant differences in pharmacokinetic parameters between the two formulations, and the relative bioavailability of the capsule versus the solution formulation was 101%. Conclusions. Similar concentration-time curves and pharmacokinetic parameters were achieved with the two formulations. The commercially available solution would be a useful alternative formulation for administration of low-dose ondansetron in research and clinical settings.

Original languageEnglish (US)
Pages (from-to)477-481
Number of pages5
JournalPharmacotherapy
Volume24
Issue number4
DOIs
StatePublished - Apr 2004

Keywords

  • Alcoholism
  • Bioavailability
  • Ondansetron

ASJC Scopus subject areas

  • Pharmacology (medical)

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