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Related Experiment Videos

Comparative bioavailability between two Tramadol once-daily oral formulations.

C Hernandez-Lopez1, L Martinez-Farnos, D Karhu

  • 1Clinical Research Department, ESTEVE, Mare de Deu de Montserrat, Barcelona, Spain. chernandez@esteve.es

Methods and Findings in Experimental and Clinical Pharmacology
|August 9, 2006
PubMed
Summary

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Tramadol Contramid once-daily demonstrated superior pharmacokinetic profiles and oral bioavailability compared to Zytram, showing significantly higher tramadol and metabolite concentrations. This suggests potential for improved efficacy in pain management.

Area of Science:

  • Pharmacology and Pharmaceutical Sciences
  • Clinical Pharmacy and Therapeutics

Background:

  • Understanding the pharmacokinetic (PK) profile and oral bioavailability of different tramadol formulations is crucial for optimizing pain management.
  • Comparing once-daily (o.d.) tramadol formulations aids in evaluating sustained release characteristics and therapeutic equivalence.

Purpose of the Study:

  • To compare the pharmacokinetic profile and oral bioavailability of Tramadol Contramid 200 mg o.d. versus Zytram 200 mg tablets.
  • To assess plasma concentrations of tramadol and its active metabolite (O-demethyltramadol) over a 24-hour dosing interval.

Main Methods:

  • Open-label, randomized, crossover study in 26 healthy volunteers with a 7-day washout period.
  • Single-dose administration of 200 mg Tramadol Contramid o.d. and Zytram.

Related Experiment Videos

  • Plasma concentrations of racemic tramadol and O-demethyltramadol (M1) analyzed using liquid chromatography/tandem mass spectrometry.

    • Main Results:

    • Tramadol Contramid o.d. exhibited significantly higher AUC(0-t), AUC(0-infinity), C(max), and C(24h) for both tramadol and O-demethyltramadol compared to Zytram.
    • Mean tramadol plasma levels remained above 200 ng/ml for 12 hours longer with Tramadol Contramid o.d. (4-16h) than with Zytram (4-6h).
    • At 24 hours, plasma concentrations of tramadol and O-demethyltramadol were 39% and 49% higher, respectively, for Tramadol Contramid o.d. (p < 0.0001).

    Conclusions:

    • Tramadol Contramid o.d. demonstrates suprabioavailability compared to Zytram o.d., indicated by higher and more sustained plasma concentrations.
    • The enhanced pharmacokinetic profile of Tramadol Contramid o.d. suggests potential for improved efficacy and possibly extended pain relief.