Bioequivalence study of two brands of meloxicam tablets in healthy human Pakistani male subjects.

Author(s): Ahmad M, Murtaza G, Akhtar N, Siddique F, Khan SA

Affiliation(s): Faculty of Pharmacy and Alternative Medicines, Islamia University of Bahawalpur, Bahawalpur-63100, Pakistan.

Publication date & source: 2011-01, Acta Pol Pharm., 68(1):115-9.

Publication type: Comparative Study; Randomized Controlled Trial

Meloxicam is a cyclooxygenase-2, preferential inhibitor non-steroidal anti-inflammatory drug (NSAID) and belongs to an enolic acid (oxicam) class used for the treatment of osteoarthritis and rheumatoid arthritis. The purpose of this single dose randomized cross-over study was to assess bioequivalence of two brands of oral meloxicam tablets (Xobix manufactured by Hilton Pharma (Pvt.) Ltd. as a reference and tablet Melfax by AGP (Pvt.) Ltd. as a test) in 18 healthy male volunteers in local population of Pakistan. The data obtained were subjected to non-compartment model pharmacokinetic analysis. The value of C(max) calculated in present study was 1.051 +/- 3.762 microg/mL for reference formulation and 1.023 +/- 4.102 microg/mL (the mean +/- SEM) for test sample. The value of T(max) was 3.125 +/- 1.004 h for reference standard and 3.750 +/- 1.469 h (the mean +/- SEM) for test sample. The area under the curve from zero to infinity (AUC(0-72)) was 28.667 +/- 0.414 microg x h/mL for reference standard and 28.367 +/- 0.333 microg x h/mL for test sample (the mean +/- SEM). The t1/2 values were 13.694 +/- 0.568 h and 13.319 +/- 0.567 h (the mean +/- SEM) for reference formulation and for test sample, respectively. The test formulation was found to be bioequivalent to reference formulation based on the pharmacokinetic parameters.