Abstract: AIM: To study the pharmacokinetics and bioequivalence of aceclofenac enter-coated tablets in healthy volunteers. METHODS: A single oral dose of 100 mg aceclofenac and the same dose of airtal were given to 20 healthy male volunteers.Aceclofenac concentrations in plasma were determined by HPLC method.The parameters of pharmacokinetics were calculated by 3p97 program. The bioequivalence and bioavailability of the two formulations were analysed. RESULTS: The Cmax of the test and reference drug were 20 ±5 and 20 ±6 mg·L ^-1, respectively;T_max were 2.7 ±0.5 and 2.0 ±0.5 h, respectively;AUC_0-24 were 55 ± 26 and 52 ± 21 mg·h ^-1·L ^-1.The 90 % confident interval for AUC_{0 -24}- ratio and C_max-ratio of the mean values of test to reference formulations were 92.2 % -120.7 % and 91.8 % - 118.9 %, respectively.The bioavailability of the tested drug was 112 %±42 %. CONCLUSIONs: There are no significant differences between the parameters of the two formulations, and the two formulations are bioequivalence.

Key words: pharmacology, aceclofenac, enter-coated tablet, pharmacokinetics, bioequivalence