• Br J Clin Pharmacol · Jan 2007

    Randomized Controlled Trial

    Comparative bioequivalence study between a novel matrix transdermal delivery system of fentanyl and a commercially available reservoir formulation.

    • Jean-Francois Marier, Mary Lor, Josée Morin, Lionel Roux, Marika Di Marco, Gaetano Morelli, and Eva Aggerholm Saedder.
    • MDS Pharma Services, Montreal (St-Laurent), Quebec, Canada.
    • Br J Clin Pharmacol. 2007 Jan 1; 63 (1): 121-4.

    AimTo determine the pharmacokinetics, safety and performance of a novel matrix formulation of fentanyl.MethodsTransdermal fentanyl was administered as the novel matrix and the Durogesic reservoir formulations (24 subjects, 100 microg h(-1)) in a randomized, fully replicate, four-way crossover study. Serum concentrations of fentanyl were assayed by LC/MS/MS. Pharmacokinetic parameters of fentanyl and performance (adherence and skin irritability) were evaluated.ResultsTest/reference ratio (90% confidence intervals) for AUC(0-t), AUC(inf) and C(max) were 105.5% (99.4, 112.0), 105.3% (99.3, 111.6) and 111.4% (100.4, 123.6), respectively. Adherence and skin irritability results of the two formulations were similar.ConclusionThe two formulations are expected to result in similar efficacy for the management of severe pain.

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