title: Bioequivalence Study of Two Orodispersible Rizatriptan Formulations of 10 mg in Healthy Volunteers.
abstract: The aim of the study was to assess the bioequivalence and tolerability of two different oral formulations of rizatriptan. A bioequivalence study was carried out in 40 healthy volunteers according to an open label, randomized, two-period, two-sequence, crossover, single dose, and fasting conditions design. The test and reference formulations were administered in two treatment days, separated by a washout period of seven days. Plasma concentrations of rizatriptan were obtained by the LC/MS/MS (Liquid chromatography tandem-mass spectrometry) method. Log-transformed AUC0-t(area under the plasma concentration-time curve from zero to the last measurable concentration) and Cmax(maximum plasma concentration) values were tested for bioequivalence based on the ratios of the geometric means (test/reference). The tmax(time to reach maximum plasma concentration) was analysed nonparametrically. The 90% confidence intervals of the geometric mean values for the test/reference ratios for AUC0-tand Cmaxwere within the bioequivalence acceptance range of 80%-125%. According to the European Guideline, it may therefore be concluded that the test formulation of rizatriptan 10 mg orodispersible tablet is bioequivalent to the reference formulation (Maxalt®Max 10 mg oral lyophilisate). The safety profile of both formulations was consistent with the summary of the product characteristics.
authors.affiliation: Laboratorios Lesvi, S.L.-Invent Farma Group, Sant Joan Despí, Barcelona 08970, Spain. mcanovas@lesvi.com.
authors.forename: Mercè
authors.initials: M
authors.lastname: Cánovas
authors.affiliation: Laboratorios Lesvi, S.L.-Invent Farma Group, Sant Joan Despí, Barcelona 08970, Spain. fpolonio@lesvi.com.
authors.forename: Francisco
authors.initials: F
authors.lastname: Polonio
authors.affiliation: Laboratorios Lesvi, S.L.-Invent Farma Group, Sant Joan Despí, Barcelona 08970, Spain. fcabre@lesvi.com.
authors.forename: Francesc
authors.initials: F
authors.lastname: Cabré
keywords: Antimigraine agent; bioequivalence; pharmacokinetics; rizatriptan