Pharmacokinetics of domestic and imported meloxicam tablets following a single dose in healthy volunteers

AIM: To compare the pharmacokinetics and relative bioavailability of domestic and imported meloxicam tablets in healthy volunteers. METHODS: In a random two periods crossover study, 12 healthy male volunteers received a single dose of meloxicam 15 mg of two formulations respectively. The plasma concentration of meloxicam was determined by HPLC method. The pharmacokinetic parameters of the two preparations and the relative bioavailability of domestic tablets were calculated with statistical analysis. RESULTS: The concentration time plots of the two preparations were in accordance with an open one compartment model with first order absorption. The main pharmacokinetic parameters of domestic and imported tablets were (67± s 14) mg· h· L -1 and (64±15) mg·h·L -1 for AUC 0-96 ; (73±19) mg·h·L -1 and (70±18) mg·h·L -1 for AUC 0-∞ ;(2.3±0.5) mg·L -1 and (1.6±0.3) mg·L -1 for C max ;(2.0±1.6) h and (6±3) h for T max ; (25±6) h and (24±5) h for T 12ke ; (40±13) h and (39±8) h for mean residence time (MRT), respectively. Variance analysis showed that there was significant difference in C max and T max but no significant difference in AUC between the two preparations. CONCLUSION: The release rate of the domestic meloxicam tablets is faster than that of the imported ones and the relative bioavailability of domestic tablets is (105±13) %.