Bioequivalence of diclofenac sodium sustained release tablets in human plasma

Objective To evaluate the bioequivalence of diclofenac sodium sustained release tablets in 20 healthy volunteers.Methods Twenty healthy male volunteers were randomly divided into 2 groups.Double-periodical crossed design was used.diclofenac sodium concentration in plasma was determined by HPLC after a single dose and a multiple doses of diclofenac sodium sustained release tablets.The relative bioavailability and related parameters of pharmacokinetics were calculated by DAS2.0 program.Results The AUC0-t of the test preparation and the reference preparation after single dose were(2 103.0±651.7) and(2 264.5±731.9)μg·h·L-1,respectively.The relative bioavailability of the test to reference preparation was(95.4±21.8)%.The AUCss of the test preparation and the reference preparation after multiple doses were(2 922.5±398.6) and(2 843.6±429.4)μg·h·L-1,respectively.The DF/τ value of reference formulation was(102.8±18.0)% of test formulation.The relative bioavailability of test to reference preparation was (103.5±10.3)%.Conclusions The results indicate that the reference preparation and the test preparation are bioequivalent.