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Pharmacokinetic study between a bilayer matrix fentalyl patch and a monolayer matrix fentanyl patch : single dose administration in healthy volunteers . AIMS Transdermal fentanyl is a well established treatment for cancer pain . The aim of the present study is to assess the relative bioavailability of fentanyl from two different transdermal systems by evaluating plasma drug concentrations after single administration of Fentalgon® ( test ) , a novel bilayer matrix type patch , and Durogesic SMAT ( reference ) , a monolayer matrix type patch . In the Fentalgon patch the upper 6 % fentanyl reservoir layer maintains a stable concentration gradient between the lower 4 % donor layer and the skin . The system provides a constant drug delivery over 72 h. METHODS This was an open label , single centre , randomized , single dose , two period crossover clinical trial , that included 36 healthy male volunteers . The patches were applied to non-irritated and non-irradiated skin on the intraclavicular pectoral area . Blood samples were collected at different time points ( from baseline to 120 h post-removal of the devices ) and fentanyl concentrations were determined using a validated LC/MS/MS method . Bioequivalence was to be claimed if the 90 % confidence interval of AUC ( 0 , t ) and C ( max ) ratios ( test : reference ) were within the acceptance range of 80-125 % and 75-133 % , respectively . RESULTS The 90 % confidence intervals of the AUC ( 0 , t ) ratio ( 116.3 % [ 109.6 , 123.4 % ] ) and C ( max ) ratio ( 114.4 % [ 105.8 , 123.8 % ] were well included in the acceptance range and the C ( max ) ratio also met the narrower bounds of 80-125 % . There was no relevant difference in overall safety profiles of the two preparations investigated , which were adequately tolerated , as expected for opioid-naïve subjects . CONCLUSIONS The new bilayer matrix type patch , Fentalgon® , is bioequivalent to the monolayer matrix type Durogesic SMAT fentanyl patch with respect to the rate and extent of exposure of fentanyl ( Eudra/CT no . 2005-000046-36 ) .
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Intervention_Pharmacological
bilayer matrix fentalyl patch and a monolayer matrix fentanyl patch
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Intervention_Pharmacological
Transdermal fentanyl
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Intervention_Pharmacological
fentanyl
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Outcome_Physical
AUC ( 0 , t ) ratio
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Outcome_Physical
acceptance range
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Outcome_Physical
C ( max ) ratio
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Outcome_Physical
tolerated
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Participant_Sample-size
36
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Participant_Sex
male volunteers