Absorption, metabolism, and excretion of etoricoxib, a potent and selective cyclooxygenase-2 inhibitor, in healthy male volunteers

Drug Metab Dispos. 2003 Feb;31(2):224-32. doi: 10.1124/dmd.31.2.224.

Abstract

[(14)C]Etoricoxib (100 microCi/dose) was administered to six healthy male subjects (i.v., 25 mg; p.o., 100 mg). Following the i.v. dose, the plasma clearance was 57 ml/min, and the harmonic mean half-life was 24.8 h. Etoricoxib accounted for the majority of the radioactivity (approximately 75%) present in plasma following both i.v. and p.o. doses. The oral dose, administered as a solution in polyethylene glycol-400, was well absorbed (absolute bioavailability of approximately 83%). Total recovery of radioactivity in the excreta was 90% (i.v.) and 80% (p.o.), with 70% (i.v.) and 60% (p.o.) excreted in urine and 20% in feces after either route of administration. Radiochromatographic analysis of the excreta revealed that etoricoxib was metabolized extensively, and only a minor fraction of the dose (<1%) was excreted unchanged. Radiochromatograms of urine and feces showed that the 6'-carboxylic acid derivative of etoricoxib was the major metabolite observed (> or =65% of the total radioactivity). 6'-Hydroxymethyl-etoricoxib and etoricoxib-1'-N-oxide, as well as the O-beta-D-glucuronide conjugate and the 1'-N-oxide derivative of 6'-hydroxymethyl-etoricoxib, were present in the excreta also (individually, < or =10% of the total radioactivity). In healthy male subjects, therefore, etoricoxib is well absorbed, is metabolized extensively via oxidation (6'-methyl oxidation >1'-N-oxidation), and the metabolites are excreted largely in the urine.

MeSH terms

  • Analysis of Variance
  • Area Under Curve
  • Cross-Over Studies
  • Cyclooxygenase 2
  • Cyclooxygenase 2 Inhibitors
  • Cyclooxygenase Inhibitors / administration & dosage
  • Cyclooxygenase Inhibitors / blood
  • Cyclooxygenase Inhibitors / metabolism*
  • Cyclooxygenase Inhibitors / urine
  • Etoricoxib
  • Feces / enzymology
  • Humans
  • Intestinal Absorption / physiology*
  • Isoenzymes / antagonists & inhibitors*
  • Isoenzymes / metabolism
  • Male
  • Membrane Proteins
  • Prostaglandin-Endoperoxide Synthases / metabolism
  • Pyridines / administration & dosage
  • Pyridines / blood
  • Pyridines / metabolism*
  • Pyridines / urine
  • Sulfones / administration & dosage
  • Sulfones / blood
  • Sulfones / metabolism*
  • Sulfones / urine

Substances

  • Cyclooxygenase 2 Inhibitors
  • Cyclooxygenase Inhibitors
  • Isoenzymes
  • Membrane Proteins
  • Pyridines
  • Sulfones
  • Cyclooxygenase 2
  • PTGS2 protein, human
  • Prostaglandin-Endoperoxide Synthases
  • Etoricoxib