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 language | English (US) |
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Pages (from-to) | 477-481 |
Number of pages | 5 |
Journal | Pharmacotherapy |
Volume | 24 |
Issue number | 4 |
DOIs | |
State | Published - Apr 2004 |
Keywords
- Alcoholism
- Bioavailability
- Ondansetron
ASJC Scopus subject areas
- Pharmacology (medical)