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The Influence of Multiple Oral Doses of Zileuton on the Steady-State Pharmacokinetics of Sulfasalazine and its Metabolites, Sulfapyridine and N-Acetylsulfapyridine

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Summary

The effects of zileuton (Abbott-64077) on the pharmacokinetics of sulfasalazine (SASP) and its metabolites, sulfapyridine (SP) and N-acetylsulfapyridine (ASP), were studied in a randomised double-blind placebocontrolled study enrolling 14 healthy male volunteers. All subjects received SASP 1g every 12 hours for 8 days and zileuton 800mg or placebo administered twice daily from day 4 to day 8 inclusive. Coadministration of zileuton did not significantly affect the area under the plasma concentration-time curve, the maximum (Cmax) or minimum (Cmin) plasma concentration and the time to Cmax of SASP, SP or ASP. Likewise, zileuton did not modify the terminal elimination half-life of SASP. It is concluded that coadministration of zileuton 1.6 g/day has no significant effects on the pharmacokinetics of SASP 2 g/day or its metabolites, SP and ASP.

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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, Rene A. Braeckman & G. Richard Granneman

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

    Charles S. Locke

  3. Immunoscience Venture, Abbott Laboratories, Abbott Park, Illinois, USA

    Louise M. Dubé

Authors
  1. Walid M. Awni
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  2. Rene A. Braeckman
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  3. Charles S. Locke
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  4. Louise M. Dubé
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  5. G. Richard Granneman
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Awni, W.M., Braeckman, R.A., Locke, C.S. et al. The Influence of Multiple Oral Doses of Zileuton on the Steady-State Pharmacokinetics of Sulfasalazine and its Metabolites, Sulfapyridine and N-Acetylsulfapyridine. Clin-Pharmacokinet 29 (Suppl 2), 98–104 (1995). https://doi.org/10.2165/00003088-199500292-00014

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  • DOI: https://doi.org/10.2165/00003088-199500292-00014

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