Bioequivalence evaluation of two oral formulations of quetiapine fumarate in healthy volunteers

Mercedes Cánovas, Ferran Torres, Gema Domenech, Jesuś Cebrecos, Pilar Pelagio, Gemma Martińez, Francisco Polonio, Francesc Cabre

Sortida de recercaRecercarevisió per companys

Resum

One bioequivalence study was carried out in healthy volunteers in order to compare the rate and extent of absorption of two oral formulations of quetiapine fumarate (CAS 111974-72-2) 25mg film-coated tablet. Thirty subjects were administered quetiapine fumarate film-coated tablet of test and reference formulation in an open-label, randomised, fasting, two-period, two-sequence, crossover study. Blood samples were taken before and within 48 h after drug administration. Plasma concentrations were determined by LC/ MS/MS. Log-transformed AUC 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%. It may be therefore concluded that the test formulation of quetiapine fumarate 25mg filmcoated tablet is bioequivalent to the reference product and can be prescribed interchangeably. © ECV • Editio Cantor Verlag.
Idioma originalEnglish
Pàgines (de-a)489-493
RevistaArzneimittel-Forschung/Drug Research
Volum61
Número d'incidència9
Estat de la publicacióPublicada - 6 d’oct. 2011

Empremta digital Navegar pels temes de recerca de 'Bioequivalence evaluation of two oral formulations of quetiapine fumarate in healthy volunteers'. Junts formen una empremta única.

Citeu això