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Clofibrate kinetics after single and multiple doses.

R Gugler, J Hartlapp

    Clinical Pharmacology and Therapeutics
    |October 1, 1978
    PubMed
    Summary
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    The study investigated chlorphenoxyisobutyric acid (CPIB) pharmacokinetics in healthy subjects. Clofibrate dosing revealed dose-dependent changes in CPIB clearance due to altered protein binding, impacting prediction of steady-state concentrations.

    Area of Science:

    • Pharmacology
    • Clinical Pharmacokinetics
    • Drug Metabolism

    Background:

    • Clofibrate is a lipid-lowering drug.
    • Understanding its pharmacokinetics, specifically chlorphenoxyisobutyric acid (CPIB) kinetics, is crucial for safe and effective dosing.
    • Plasma protein binding can significantly influence drug disposition.

    Purpose of the Study:

    • To characterize the pharmacokinetics of CPIB after single and multiple doses of clofibrate in healthy subjects.
    • To investigate the impact of dose and duration on CPIB plasma concentrations and clearance.
    • To determine the role of plasma protein binding in CPIB disposition.

    Main Methods:

    • Single oral doses of clofibrate (500 mg, 1000 mg, 2000 mg) administered to 5 healthy subjects.
    • Steady-state kinetics assessed after 8 days of 1000 mg twice daily clofibrate.

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  • Plasma concentrations of CPIB measured over time.
  • Plasma protein binding of CPIB determined.
  • Total and unbound CPIB clearance calculated.

    • Main Results:

    • Mean plasma half-life of CPIB was approximately 16.7 hours, independent of dose and treatment duration.
    • Total plasma clearance of CPIB increased with higher doses (2000 mg) and steady-state treatment.
    • Increased clearance correlated with reduced plasma protein binding of CPIB at concentrations above 50 microgram/ml.
    • Clearance and volume of distribution were consistent when calculated using only unbound CPIB concentrations.

    Conclusions:

    • Plasma protein binding of CPIB is inconsistently affected by clofibrate concentration.
    • This variable protein binding prevents accurate prediction of total steady-state CPIB concentrations from single-dose data.
    • Dose adjustments and monitoring of unbound concentrations may be necessary for optimizing clofibrate therapy.