Bioequivalence study of two meloxicam tablet formulations after single-dose administration in healthy Thai male volunteers

Abstract

To compare the bioavailability of two meloxicam tablet formulations (MEL-OD, Zydus Cadila Healthcare Limited, India, as a test formulation and Mobic, Boehringer Ingelheim International GmbH, Germany, as a reference formulation) in healthy Thai male volunteers under fasting condition. A randomized, 2-treatment, 2-period, 2-sequence, single dose, crossover with a washout period of 2 weeks, was conducted in 26 healthy Thai male volunteers. Blood samples were collected 0, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12, 24, 36, 48, 72 and 96 h post dose. Plasma concentrations of meloxicam were determined using a validated HPLC method. The pharmacokinetic parameters of meloxicam were determined using a non-compartmental model. The mean Cmax was 1,027.32 +/- 251.91 and 1,151.89 +/- 282.58 ng/ml while the mean AUC0-t was 34,024.31 +/- 11,811.68 and 35,137.66 +/- 11,970.47 ng x h/ml for the test and reference formulation, respectively. In addition, the mean AUC0-infinity for test formulation was 37,241.44 +/- 14,888.85 ng x h/ml and for the reference formulation was 39,541.04 +/- 16,624.64 ng x h/ml. The median tmax for the test and reference formulation was 4.50 (range 2.00 - 12.00) and 4.50 (range 3.00 - 10.00), respectively. The geometric means (90% confidence intervals) of the ratio for the log-transformed pharmacokinetic parameters, Cmax, AUC0-t and AUC0-inf were 0.8919 (82.58 - 96.32%), 0.9697 (89.46 - 105.10%) and 0.9525 (87.68 - 103.47%), respectively. It can be concluded that two meloxicam tablet formulations are bioequivalent both in term of rate and extent of absorption after single-dose administration under fasting condition.