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


CONCLUSIONS
Ibuprofen arginate approaches maximum concentrations of S(+)-ibuprofen faster and higher than dexibuprofen.
Sádaba
Belén
B
Clinical Research Unit, Clínica Universitaria de Navarra, Universidad de Navarra, 31008, Pamplona, Spain. bsadaba@unav.es
Campanero
Miguel A
MA
Muñoz-Juarez
Maria Jose
MJ
Gil-Aldea
Isabel
I
García-Quetglas
Emilio
E
Esteras
Antonio
A
Azanza
Jose R
JR
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000465:Algorithms; D000704:Analysis of Variance; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001120:Arginine / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics*; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D004844:Epistaxis / Q000139:chemically induced; D005260:Female; D006207:Half-Life; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007052:Ibuprofen / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics*; D008297:Male; D008657:Metabolic Clearance Rate; D013237:Stereoisomerism; D013810:Therapeutic Equivalency; D013997:Time Factors
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D001120:Arginine; D007052:Ibuprofen; C106674:ibuprofen arginine