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Is Once‐Daily Mesalazine Equivalent to the Currently Used Twice‐Daily Regimen? A Study Performed in 30 Healthy Volunteers
Author(s) -
Gandia Peggy,
Idier Isabelle,
Houin Georges
Publication year - 2007
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270006296522
Subject(s) - mesalazine , bioequivalence , dosing , medicine , regimen , pharmacokinetics , crossover study , dose , confidence interval , pharmacology , randomized controlled trial , inflammatory bowel disease , alternative medicine , disease , pathology , placebo
A randomized, 2‐way, crossover study was conducted in 30 volunteers to compare the pharmacokinetic profile of a new once‐daily dosing regimen of mesalazine (1 × 4 g/d) with the current twice‐daily dosage (2 × 2 g/d) used in many European countries. The 2 dosages were administrated orally for 8 days, separated by a 2‐week washout. Plasma concentrations of mesalazine and N‐acetyl‐mesalazine were determined on days 1 and 8 by a validated high‐performance liquid chromatography method and C max , t max , and AUCs calculated. The bioequivalence was obtained for a 90% confidence interval of the AUC 0–24h ratio (test/reference) for mesalazine and N‐acetyl‐mesalazine on days 1 and 8, within the range of 0.80 to 1.25. The bioequivalence was demonstrated on day 1 for mesalazine and N‐acetyl‐mesalazine and on day 8 for mesalazine. As it is desirable to offer patients a preparation with a less frequent administration to enhance compliance, this once‐daily regimen may be an attractive dosing option.