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Clinical Pharmacokinetics

, Volume 29, Supplement 2, pp 62–66 | Cite as

The Effect of Food on the Pharmacokinetics of Zileuton

  • Walid M. Awni
  • John H. Cavanaugh
  • Galen Witt
  • G. Richard Granneman
  • Louise M. Dubé
Article

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.

Keywords

Single Oral Dose Hepatic Blood Flow Zileuton High Performance Liquid Chroma Statistical Analysis System Institute 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Adis International Limited 1995

Authors and Affiliations

  • Walid M. Awni
    • 1
  • John H. Cavanaugh
    • 2
  • Galen Witt
    • 3
  • G. Richard Granneman
    • 1
  • Louise M. Dubé
    • 4
  1. 1.Pharmacokinetics and Biopharmaceutics DepartmentAbbott Laboratories, D4PK, AP13AAbbott ParkUSA
  2. 2.Clinical Pharmacology DepartmentAbbott LaboratoriesAbbott ParkUSA
  3. 3.Statistics DepartmentAbbott LaboratoriesAbbott ParkUSA
  4. 4.The Immunoscience VentureAbbott LaboratoriesAbbott ParkUSA

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