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Related Experiment Videos

Comparative bioavailability of trazodone formulations using stable isotope methodology.

R E Gammans, A V Mackenthun, J W Russell

    British Journal of Clinical Pharmacology
    |September 1, 1984
    PubMed
    Summary

    This study assessed trazodone antidepressant bioavailability from two tablet formulations versus an oral solution. Both tablet forms demonstrated bioequivalence to the oral solution, supporting their therapeutic use.

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    Area of Science:

    • Pharmacokinetics and Drug Bioavailability
    • Pharmaceutical Sciences
    • Clinical Pharmacology

    Background:

    • Trazodone is a widely prescribed antidepressant.
    • Understanding the bioavailability of different trazodone formulations is crucial for ensuring therapeutic efficacy.
    • Dividose and film-sealed tablets are common dosage forms.

    Purpose of the Study:

    • To determine the bioavailability of trazodone from 50 mg dividose and film-sealed tablets compared to an oral solution.
    • To assess the bioequivalence of the two tablet formulations.
    • To evaluate potential isotope effects using a stable isotope-labeled standard.

    Main Methods:

    • A crossover study involving six healthy male subjects.
    • Administration of 50 mg trazodone in three forms: dividose tablet, film-sealed tablet, and oral solution.

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  • Quantification of trazodone and D4-trazodone (stable isotope-labeled standard) concentrations using Gas Chromatography-Mass Spectrometry (GCMS).

    • Main Results:

    • Pharmacokinetics of trazodone and D4-trazodone were identical, confirming no isotope effect.
    • Relative Cmax values (trazodone/D4-trazodone) were 0.84 ± 0.09 for dividose tablets, 0.90 ± 0.05 for film-sealed tablets, and 1.05 ± 0.04 for the oral solution.
    • The dosage forms achieved a relative bioequivalence power of 85%.

    Conclusions:

    • Both dividose and film-sealed trazodone tablets are bioequivalent to the oral solution.
    • The findings support the use of these tablet formulations for delivering trazodone effectively.
    • No significant isotope effect was observed, validating the use of D4-trazodone as a standard.