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Related Experiment Videos

Bioavailability of three isoniazid formulations

S Sved, I J McGilveray, N Beaudoin

    Journal of Pharmaceutical Sciences
    |December 1, 1977
    PubMed
    Summary

    This study found no significant differences in the bioavailability of three isoniazid formulations among slow acetylator volunteers. All tested isoniazid tablets demonstrated comparable pharmacokinetic profiles in human subjects.

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    Area of Science:

    • Pharmacokinetics
    • Drug bioavailability
    • Clinical pharmacology

    Background:

    • Isoniazid is a primary drug for tuberculosis treatment.
    • Assessing the bioavailability of different drug formulations is crucial for therapeutic efficacy.
    • Slow acetylators represent a specific patient population with altered drug metabolism.

    Purpose of the Study:

    • To compare the bioavailability of three distinct isoniazid tablet formulations.
    • To evaluate key pharmacokinetic parameters (Cmax, tmax) across different isoniazid products.
    • To identify potential formulation-dependent variations in isoniazid absorption.

    Main Methods:

    • A crossover study design involving nine human volunteers (slow acetylators).
    • Administration of three different isoniazid (400 mg) tablet formulations at weekly intervals.
    • Measurement of plasma isoniazid concentrations over 24 hours post-administration.

    Main Results:

    • No statistically significant differences were observed in relative bioavailability, peak plasma concentrations (Cmax), or time to peak concentration (tmax) among the three isoniazid formulations.
    • Pharmacokinetic analysis using a one-compartment open model showed no significant formulation or time effects.
    • A significant intersubject variation in pharmacokinetic parameters was noted, indicating individual differences in drug handling.

    Conclusions:

    • The three evaluated isoniazid formulations exhibit comparable bioavailability and pharmacokinetic profiles in slow acetylator individuals.
    • Formulation does not appear to be a major determinant of isoniazid bioavailability in this population.
    • Inter-individual variability in drug metabolism is a significant factor influencing isoniazid pharmacokinetics.

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