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Sci. Pharm. 2016, 84(3), 514-522;

Bioequivalence Study of Two Orodispersible Rizatriptan Formulations of 10 mg in Healthy Volunteers

Laboratorios Lesvi, S.L.-Invent Farma Group, Sant Joan Despí, Barcelona 08970, Spain
Author to whom correspondence should be addressed.
Academic Editor: Thomas Erker
Received: 27 November 2015 / Accepted: 24 January 2016 / Published: 13 June 2016
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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-t and Cmax were 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. View Full-Text
Keywords: Antimigraine agent; rizatriptan; bioequivalence; pharmacokinetics Antimigraine agent; rizatriptan; bioequivalence; pharmacokinetics

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Cánovas, M.; Polonio, F.; Cabré, F. Bioequivalence Study of Two Orodispersible Rizatriptan Formulations of 10 mg in Healthy Volunteers. Sci. Pharm. 2016, 84, 514-522.

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