Pharmacokinetics and Bioequivalence of Meloxicam Orally Disintegrating Tablets in Healthy Volunteers

OBJECTIVE: To study the bioequivalence of meloxicam orally disintegrating tablets in healthy volunteers. METHODS: The randomized crossover and self-control study was conducted in 22 healthy volunteers. They were treated with a single oral dose of 7.5mg of meloxicam orally disintegrating tablets or a single oral dose of control drug (meloxicam tablets) and the blood drug concentrations were measured by HPLC . RESULTS: The mean Cmax was(1 501.14±323.76)ng/ml for meloxicam orally disintegrating tablets and(1 563.74±417.94)ng/ml for meloxicam tablets ; the mean tmax was(4.77±2.20)and (4.96±2.24)h respectively;t1/2 was(24.28±6.59)and(24.76±7.35)h respectively;AUC0～t was(49 179.57±12 214.63)and(51 414.97±14 419.56)(ng·h)/ml respectively. The relative bioavailability of meloxicam orally disintegrating tablets was(98.09±18.03)%. CONCLUSION: There are no significant differences between the major pharmacokinetic parameters of meloxicam orally disintegrating tablets and meloxicam tablets. Meloxicam orally disintegrating tablets and meloxicam tablets are bioequivalent.