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

From the Laboratoire de Pharmacocinétique et Toxicologie Clinique, Institut Fédératif de Biologie, Hôpital Purpan, Toulouse, France (Dr Gandia, Dr Houin); Ferring SAS, Gentilly, France (Dr Idier).

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 x 4 g/d) with the current twice-daily dosage (2 x 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.

Key Words: Mesalazine • bioequivalence • oral administration

Address for reprints: Address for correspondence: Peggy Gandia, PharmD, PhD, Laboratoire de Pharmacocinétique et Toxicologie Clinique, Institut Fédératif de Biologie, Hôpital Purpan, TSA 70034, 330 avenue de Grande Bretagne, 31059 Toulouse cedex 9, France.

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