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

Full 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.

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Author information

Author/s: Sádaba, Belén (B); Campanero, Miguel A (MA); Muñoz-Juarez, Maria Jose (MJ); Gil-Aldea, Isabel (I); García-Quetglas, Emilio (E); Esteras, Antonio (A); Azanza, Jose R (JR);

Affiliation: Clinical Research Unit, Clínica Universitaria de Navarra, Universidad de Navarra, 31008, Pamplona, Spain. bsadaba(-atsign-)unav.es

Journal and publication information

Publication Type: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: European journal of clinical pharmacology (Eur J Clin Pharmacol), published in Germany. (Language: eng)

Reference: 2006-Oct; vol 62 (issue 10) : pp 849-54

Dates: Created 2006/10/05; Completed 2007/12/12;

PMID: 16909273, status: MEDLINE (last retrieval date: 12/26/2008)

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Administration, Oral
Adolescent
Adult
Algorithms
Analysis of Variance
Anti-Inflammatory Agents, Non-Steroidal - administration & dosage; adverse effects; pharmacokinetics
Area Under Curve
Arginine - blood; chemistry; 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; chemistry; pharmacokinetics
Male
Metabolic Clearance Rate
Stereoisomerism
Therapeutic Equivalency
Time Factors

Associated Chemicals: Anti-Inflammatory Agents, Non-Steroidal (0) ; Drug Combinations (0) ; ibuprofen arginine (0) ; Ibuprofen (15687-27-1) ; Arginine (74-79-3)

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