Bioequivalence evaluation of two dosage forms of olanzapine 10 mg formulations in healthy volunteers

Mercedes Cánovas, Ferran Torres, Gema Domenech, Jesús Cebrecos, Pilar Pelagio, Marcela Manríquez, Gemma Martínez, Marta Arcabell, Francesc Cabré

Research output: Contribution to journalArticleResearchpeer-review

6 Citations (Scopus)

Abstract

Two bioequivalence studies were carried out in healthy volunteers in order to compare the rate and extent of absorption of two dosage forms (film-coated tablet and orodispersible tablet) of oral olanzapine (CAS 132539-06-1) 10 mg test formulations and the respective brand formulations as reference. Twenty and twenty-six subjects were administered olanzapine film-coated tablet or orodispersible tablet of test and reference formulations in an open-label, randomised, fasting, two-period, two-sequence, crossover study. Blood samples were taken before and within 240 h after drug administration. Plasma concentrations were determined by LC/MS/MS. Log-transformed AUC and C max 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 formulations of olanzapine 10 mg film-coated tablet and orodispersible tablet are bioequivalent to the reference products and can be prescribed interchangeably. © ECV • Editio Cantor Verlag.
Original languageEnglish
Pages (from-to)75-79
JournalArzneimittel-Forschung/Drug Research
Volume61
Issue number2
Publication statusPublished - 11 Mar 2011

Keywords

  • Atypical antipsychotic
  • Bioequivalence
  • CAS 132539-06-1
  • Healthy volunteers
  • Olanzapine, tablet
  • Pharmacokinetics

Fingerprint Dive into the research topics of 'Bioequivalence evaluation of two dosage forms of olanzapine 10 mg formulations in healthy volunteers'. Together they form a unique fingerprint.

Cite this