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

Acta Pol Pharm. 2011 Jan-Feb;68(1):115-9.

Abstract

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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Area Under Curve
  • Cross-Over Studies
  • Cyclooxygenase 2 Inhibitors / administration & dosage
  • Cyclooxygenase 2 Inhibitors / blood
  • Cyclooxygenase 2 Inhibitors / pharmacokinetics*
  • Half-Life
  • Humans
  • Male
  • Meloxicam
  • Models, Biological
  • Pakistan
  • Reference Standards
  • Tablets
  • Therapeutic Equivalency
  • Thiazines / administration & dosage
  • Thiazines / blood
  • Thiazines / pharmacokinetics*
  • Thiazoles / administration & dosage
  • Thiazoles / blood
  • Thiazoles / pharmacokinetics*
  • Young Adult

Substances

  • Cyclooxygenase 2 Inhibitors
  • Tablets
  • Thiazines
  • Thiazoles
  • Meloxicam