Relative bioavailability and bioequivalent evaluation of paracetamol and caffeine in Afenca tablets

OBJECTIVE To investigate the relative bioavailability and bioequivalence of paracetamol and caffeine in Afenca tablets(AFC).METHODSThe concentration of paracetamol and caffeine in plasma was detected by RP-HPLC after 24 healthy male volunteers being treated with a single oral dose of AFC and reference preparations.RESULTS The relative bioavailability of paracetamol was 100.72%±11.33 %.AUC0-T of paracetamol of test and reference preparations were 12.86±3.20 μg·h·ml-1 and 12.92±3.56 μg·h·ml-1;Tmax were 1.1±0.4 h and 1.1±0.4 h;Cmax were 3.25±0.57 μg·ml-1 and 3.31±0.61 μg·ml-1.The relative bioavailability of caffeine was 101.96%±13.65 %.AUC0-T of caffeine of test and reference preparations were 10.61±1.50 μg·h·ml-1 and 10.32±1.80 μg·h·ml-1;Tmax were 1.0±0.4 h and 1.0±0.3 h;Cmax were 1.74±0.20 μg·ml-1 and 1.68±0.25 μg·ml-1.CONCLUSIONBioequivalent evaluation of two preparations by analyzing with two one-way test shows that paracetamol and caffeine in the two preparations are bioequivalent.