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The Effect of Food on the Pharmacokinetics of Zileuton

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Summary

The present study was undertaken to assess the effect of food on the pharmacokinetic parameters of zileuton. In a nonblinded crossover study, 18 healthy male volunteers who had fasted overnight were randomised to receive a single oral dose of zileuton 600mg in the presence or absence of food consisting of a standardised breakfast on the following morning. The mean zileuton peak plasma concentration (Cmax) increased significantly by 27% after food intake, while the mean area under the plasma concentration versus time curve increased by only 1.4%, a difference that was not statistically significant. The mean time to Cmax was unaffected by the presence of food, as were the other pharmacokinetic parameters assessed.

Overall, the results suggest that food has a relatively small effect on the rate of zileuton absorption compared with the fasting state, while the bioavailability of the drug appears to be unaffected. Thus, it is concluded that it is appropriate to administer zileuton with or without food.

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Authors and Affiliations

  1. Pharmacokinetics and Biopharmaceutics Department, Abbott Laboratories, D4PK, AP13A, 100 Abbott Park Road, Abbott Park, Illinois, 60064-3500, USA

    Walid M. Awni & G. Richard Granneman

  2. Clinical Pharmacology Department, Abbott Laboratories, Abbott Park, Illinois, USA

    John H. Cavanaugh

  3. Statistics Department, Abbott Laboratories, Abbott Park, Illinois, USA

    Galen Witt

  4. The Immunoscience Venture, Abbott Laboratories, Abbott Park, Illinois, USA

    Louise M. Dubé

Authors
  1. Walid M. Awni
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  2. John H. Cavanaugh
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  3. Galen Witt
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  4. G. Richard Granneman
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  5. Louise M. Dubé
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Awni, W.M., Cavanaugh, J.H., Witt, G. et al. The Effect of Food on the Pharmacokinetics of Zileuton. Clin-Pharmacokinet 29 (Suppl 2), 62–66 (1995). https://doi.org/10.2165/00003088-199500292-00009

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  • DOI: https://doi.org/10.2165/00003088-199500292-00009

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