A comparative study of the pharmacokinetics of ibuprofen arginate versus dexibuprofen in healthy volunteers

Eur J Clin Pharmacol. 2006 Oct;62(10):849-54. doi: 10.1007/s00228-006-0180-5. Epub 2006 Aug 15.

Abstract

Objective: Ibuprofen arginate is a salt formulation of ibuprofen designed to reach target concentrations rapidly. The primary objective of this study was to compare the 12-h pharmacokinetic profile of S(+)-ibuprofen following administration of single doses of ibuprofen arginate (600 mg) and dexibuprofen (400 mg) in healthy volunteers.

Methods: Twenty-four volunteers were recruited into an open-label, randomised, two-period, single-centre study with crossover design.

Results: Both treatments were well tolerated. Ibuprofen arginate and dexibuprofen showed similar bioavailability for S(+)-ibuprofen. Compared with dexibuprofen, ibuprofen arginate demonstrated a 45% higher maximum concentration (C(max)), and a time to peak concentration (T(max)) 2 h sooner.

Conclusion: Ibuprofen arginate approaches maximum concentrations of S(+)-ibuprofen faster and higher than dexibuprofen.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Algorithms
  • Analysis of Variance
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Anti-Inflammatory Agents, Non-Steroidal / pharmacokinetics*
  • Area Under Curve
  • Arginine / blood
  • Arginine / chemistry
  • Arginine / pharmacokinetics*
  • Biological Availability
  • Chromatography, High Pressure Liquid
  • Cross-Over Studies
  • Dose-Response Relationship, Drug
  • Drug Combinations
  • Epistaxis / chemically induced
  • Female
  • Half-Life
  • Headache / chemically induced
  • Humans
  • Ibuprofen / blood
  • Ibuprofen / chemistry
  • Ibuprofen / pharmacokinetics*
  • Male
  • Metabolic Clearance Rate
  • Stereoisomerism
  • Therapeutic Equivalency
  • Time Factors

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Drug Combinations
  • Arginine
  • Ibuprofen
  • ibuprofen arginine