The pharmacokinetics of aspirin sustained-release tablets in health volunteers

OBJECTIVE:To study the pharmacokinetics and relative bioavailability of aspirin sustaried release tablets in health volunteers.METHODS:Twelve male health volunteers orally took a single and multiple doses of the tablets and enteric coating tablets in an open randomized crossover study.Plasma concentrations of salicylic acid were tested by HPLC.RESULTS:The plasma concentration time curves of these two drugs appeared to fit oral first order absorption and one compartment open model after a single oral dose.The peak levels in plasma averaged ( 3.8 ± 0.4 ) and ( 9.5 ± 1.8 )mg·L -1 at ( 5.5 ± 0.5 ) and ( 5.4 ± 0.8 )h and the AUC were ( 66.5 ± 12.5 ) and ( 64.5 ± 8.9 )mg·h·L -1 ,respectively.The relative bioavailabilety of sustarned realease tablets was ( 103.5 ± 12.3 )%.Following multiple dosing mean steady state, C max values were ( 3.8 ± 0.5 ) and ( 9.7 ± 1.5 )mg·h·L -1 and C min were ( 1.25 ± 0.27 )mg·L -1 and ( 0.49 ± 0.25 )mg·L -1 ,respectively.The peak to through fluctuation index(FI) for the two formulations were 0.86 ± 0.23 and 1.73 ± 0.16 respectively.CONCLUSIONS:The sustarned release tablets had an obvious slow release characteristics. [