In vivo pharmacokinetics and bioequivalence of meloxicam dispersion tablets in healthy volunteers

Objective To investigate in vivo pharmacokinetics and bioavailability of meloxicam dispersion tablets in 24 healthy volunteers. Methods This was a double-preparation, double-cycle, cross-over study. Subjects received a single dose of 15 mg meloxicam administered in experimental and reference preparation, respectively. The plasma concentration of meloxicam was determined by using high-performance liquid chromatography. Results Meloxicam exhibited considerable linearity (r=0.9996), with mean recovery rate of 89.43%~103.17% as well as within-day and between-day RSD of less than 6% in the concentration range of 0.015～3 μg/ml. Pharmacokinetic parameters of experimental and reference preparations were ordered as follows: (22±7) and (22±7) h for half time (t1/2), (1.32±0.27) and (1.42±0.32) mg/L for Cmax, (4.6±1.1) and (4.8±1.9) h for Tmax, (42±14) and (45±14) mg·h-1·L-1 for AUC0~96, as well as (45±17) and (48±18) mg·h-1·L-1 for AUC0~∞, respectively. The relative bioavailability of experimental preparation was (93±10)% versus reference preparation. Based on analysis of variance and two-sided t-test, lnAUC, lnCmax and Tmax did not differ statistically (P0.05) between both preparations. Conclusion Meloxicam dispersion tablet is of bioequivalence to reference preparation.