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A study to evaluate the effect of ondansetron on psychomotor performance after repeated oral dosing in healthy subjects

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Abstract

The aim of the study was to determine the effect of repeated oral administration of ondansetron, a 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist, on psychomotor performance. The study was of a randomised, double-blind, four-way, cross-over design in 12 healthy subjects, with 1 mg and 8 mg ondansetron, placebo and 2 mg lorazepam evaluated. Each subject received five administrations per treatment period. Ondansetron, 1 mg and 8 mg, and placebo were given as twice daily dosing for 2 1/2 days. Lorazepam was administered as a 2 mg single oral dose which was taken as the fifth administration; placebo was given for the remaining four doses. Within each treatment period, subjects underwent a baseline (pre-dose) assessment of psychomotor performance using four commonly used and validated psychomotor tests, and were then re-assessed after the fifth and final dose over a 7-h, post-dose period. Following dosing with lorazepam, statistically significant changes were seen in five of the six test variables compared with placebo. Ondansetron, at both the 1 mg and the 8 mg doses, did not produce a statistically significant effect on any measure of psychomotor performance compared with placebo.

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Hall, S.T., Ceuppens, P.R. A study to evaluate the effect of ondansetron on psychomotor performance after repeated oral dosing in healthy subjects. Psychopharmacology 104, 86–90 (1991). https://doi.org/10.1007/BF02244559

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Key words

  • Ondansetron
  • Lorazepam
  • Psychomotor performance
  • Healthy subjects