Bioequivalence of Paracetamol/Caffeine Orally Disintegrating Tablets in Healthy Volunteers

According to a randomized cross-over design,the bioequivalence of paracetamol/caffeine orally disin-tegrating tablets(test preparation) and its conventional tablets(reference preparation) in eighteen healthy volunteers were investigated.The plasma con centration of paracetamol and caffeine were determined by HPLC.After oral administration of paracetamol 500mg and caffeine 65mg,the main pharmacokinetic parameters of paracetamol for test preparation and reference preparartion were cmax(8450±1300) and(9350±1870)μg/L,tmax(0.6±0.3) and(0.7±0.3)h,AUC0→24(32680± 7550) and(31280±6570)μg.h.L–1,the main pharmacokinetic parameters of caffeine for test preparation and reference preparartion were cmax(1649±303) and(1659±272)μg/L,tmax(0.6±0.1) and(0.6±0.1)h,AUC0→24(10711±2743) and(10384±2948)μg.h.L–1.The relative bioavailability of orally disintegrating tablets was(105.1±13.8)% with paracetamol and(100.7±10.1)% with caffeine.The results of ANOVA analysis showed that the test and reference preparations were bioequivalent.