COMPARATIVE BIOAVAILABILITY STUDY OF TWO MELOXICAM PREPARATIONS

ABSTRACT

Objective   To evaluate the relative bioavialability of two oral formulations of 15-mg of meloxicam tablets. Methods The study was conducted as an open label, two-way, crossover design with a washout period of 2-weeks. Twelve healthy male volunteers were given either one tablet of the test formulation or the same dose of the innovator after fasting. Blood samples were collected at 96 h postdose. The plasma was separated and the concentrations of meloxicam were determined by the HPLC method. Results The mean Cmax (ng/mL) was 1,509.80 and 1,379.94, while the mean AUC 0-∞ (ng.h/ mL) was 62,770.29 and 57,752.81 for the test and reference, respectively. The average Tmax (h) and half-life (h) of the test (6.25, 25.44) were slightly longer than those of the reference (5.33, 23.42). The relative bioavailability (%) with respect to the Cmax and AUC 0-∞ was 109.60 and 108.18, while, the mean (90% CI) after logarithmical (ln) transformation was 1.09 (0.97- 1.22) and 1.07 (1.02-1.13), respectively. No significant differences in pharmacokinetic parameters between the two formulations were found. Therefore, the study concluded that the bioavailability of the two meloxicam formulations are bioequivalent in terms of rate and extent of absorption. Chiang Mai Med Bull 2005;44(3)91-100.