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

Research output: Contribution to journalArticleResearchpeer-review

Abstract

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.
Original languageEnglish
Pages (from-to)489-493
JournalArzneimittel-Forschung/Drug Research
Volume61
Issue number9
Publication statusPublished - 6 Oct 2011

Keywords

  • Atypical antipsychotic
  • Bioequivalence
  • Healthy volunteers
  • Pharmacokinetics
  • Quetiapine fumarate, tablet

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