Is Once-Daily Mesalazine Equivalent to the Currently Used Twice-Daily Regimen? A Study Performed in 30 Healthy Volunteers


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Abstract

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 Cmax, tmax, and AUCs calculated. The bioequivalence was obtained for a 90% confidence interval of the AUC0–24h 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.

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