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Oxaprozin dose proportionality.

S T Chiang, K C Lasseter, E R Fluck

    Journal of Clinical Pharmacology
    |November 1, 1984
    PubMed
    Summary
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    Oxaprozin dosing showed that total drug levels did not proportionally increase with higher doses. However, unbound oxaprozin pharmacokinetics remained linear and dose-proportional, indicating predictable drug behavior.

    Area of Science:

    • Pharmacology
    • Clinical Pharmacy
    • Drug Metabolism

    Background:

    • Oxaprozin is a nonsteroidal anti-inflammatory drug (NSAID).
    • Understanding its dose-dependent pharmacokinetics is crucial for safe and effective therapeutic use.
    • Plasma protein binding can influence drug distribution and elimination.

    Purpose of the Study:

    • To investigate the dose-proportionality of oxaprozin pharmacokinetics in healthy subjects.
    • To evaluate the impact of varying plasma protein binding on oxaprozin's disposition.
    • To determine if oxaprozin exhibits linear pharmacokinetics across a range of oral doses.

    Main Methods:

    • A three-period crossover study design was employed.
    • Twelve healthy subjects received single oral doses of 300, 600, and 1200 mg of oxaprozin.

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  • Plasma concentrations, unbound fraction (fup), total clearance (CLo), volume of distribution (Vd), and elimination half-life were measured.

    • Main Results:

    • Total plasma oxaprozin concentrations did not increase proportionally with dose.
    • Total clearance and volume of distribution increased with dose.
    • The fraction of unbound oxaprozin in plasma (fup) increased linearly with total plasma concentration.
    • Unbound volume of distribution (Vdu) and intrinsic clearance (CLi) remained constant across doses.
    • Unbound oxaprozin pharmacokinetics demonstrated dose-proportionality.

    Conclusions:

    • Oxaprozin exhibits linear pharmacokinetics for its unbound fraction, irrespective of dose.
    • Protein binding does not significantly alter unbound oxaprozin plasma levels within the studied dose range.
    • The dose administered is directly proportional to the unbound drug concentration in plasma.