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Arzneimittelforschung 2012; 62(10): 482-486
DOI: 10.1055/s-0032-1321848
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

Bioequivalence Study of 2 Orodispersible Formulations of Zolmitriptan 5 mg in Healthy Volunteers

M. Cánovas   *
1   Laboratorios Lesvi, S.L.- Invent Farma Group, Sant Joan Despí, Barcelona, Spain
,
M. Canals
1   Laboratorios Lesvi, S.L.- Invent Farma Group, Sant Joan Despí, Barcelona, Spain
,
F. Polonio
1   Laboratorios Lesvi, S.L.- Invent Farma Group, Sant Joan Despí, Barcelona, Spain
,
F. Cabré
1   Laboratorios Lesvi, S.L.- Invent Farma Group, Sant Joan Despí, Barcelona, Spain
› Institutsangaben
Weitere Informationen

Publikationsverlauf

received 27. April 2012

accepted 04. Juli 2012

Publikationsdatum:
23. August 2012 (online)

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Abstract

A bioequivalence study of 2 zolmitriptan (CAS 139264-17-8) orodispersible tablet formulations was carried out in 26 healthy volunteers according to an open label, randomized, 2-period, 2-sequence, crossover, single dose and fasting conditions design. The test and reference formulations were administered in 2 treatment days, separated by a washout period of 7 days. Plasma concentrations of zolmitriptan and its active metabolite (N-desmethyl-zolmitriptan) were obtained by LC/MS/MS method. Log-transformed AUCs and Cmax values were tested for bioequivalence based on the ratios of the geometric means (test/reference). Tmax 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 [1] it may be therefore concluded that test formulation of zolmitriptan 5 mg orodispersible tablet is bioequivalent to the reference formulation.

Key words

antimigraine agent - bioequivalence - CAS 139264-17-8 - zolmitriptan - pharmacokinetics
*

* working at the institution at the time of the trial


 

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