The Relative Bioavailability of Meloxicam Tablet in Healthy Volunteers

OBJECTIVE:A single oral dose of 15mg test meloxicam tablet or its reference was given to 24 healthy male volunteers in a randomized crossover study. METHODS: Meloxicam concentrations in plasma were determined by HPLC method. The pharmacokinetic and bioavailability of test tablet were compared with reference. RESULTS: The concentration-time curves of the two preparations were fitted into a two-compartment model. The Cmax of test meloxicam tablet and reference were 1 .34±0.35mg·L·－１ and 1 .03±0.22mg·L-1, the tpeak were 2. 15±1 .59h and 5.28±2. 10h, the t1/2β were 33.90±24.56h and 31.25±17. 17 h, the AUC 0-inf were 39.67±10.64mg·h·L-1 and 38.65±10.63mg·h· L-1,respectively The relative bioavailability of the test meloxicam tablet was 104.3±17.8%. CONCLUSION: Through the analysis of covariance, the one two-side test and 90% confidential interval test, there was no significant difference between the two preparations. The two preparations are bioequivalent. There were only few mild adverse effects found during the test period.