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Related Experiment Videos

Single dose bioavailability of two different digoxin tablets.

J H Jonkman, C F Gusdorf, W J van der Boon

    Arzneimittel-Forschung
    |January 1, 1987
    PubMed
    Summary

    This study compared two digoxin tablets, finding no significant differences in absorption or bioavailability. Both products demonstrated bioequivalence, suggesting they are interchangeable for patients.

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    Area of Science:

    • Pharmacokinetics
    • Pharmaceutical Sciences

    Background:

    • Digoxin is a critical medication for managing heart conditions.
    • Ensuring bioequivalence between different digoxin formulations is essential for therapeutic consistency.

    Purpose of the Study:

    • To compare the pharmacokinetic profiles and bioavailability of two digoxin 0.25 mg tablet formulations (digoxin-Pharbita and a reference drug).
    • To assess the relationship between in vitro dissolution rates and in vivo performance of the digoxin tablets.

    Main Methods:

    • A single-dose, randomized bioequivalence study was conducted in 10 healthy adults.
    • Digoxin plasma concentrations were measured using radioimmunoassay up to 24 hours post-administration.
    • In vitro dissolution testing was performed on both tablet formulations.

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    Main Results:

    • No statistically significant differences were observed in key pharmacokinetic parameters (Cmax, Tmax, AUC0-10) between the two digoxin products.
    • Product A showed a slightly faster absorption profile and higher peak plasma concentrations in most subjects.
    • Relative bioavailability of Product A compared to the reference drug was 97.7 +/- 28.7%.

    Conclusions:

    • The two digoxin tablet formulations are bioequivalent.
    • The findings support the interchangeability of these digoxin products in clinical practice.