title: Bioequivalence evaluation of two dosage forms of olanzapine 10 mg formulations in healthy volunteers.
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 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 AUC(0-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.
authors.affiliation: Laboratorios Lesvi, S.L.-Invent Farma Group, Sant Joan Despí, Barcelona, Spain. mcanovas@lesvi.com
authors.forename: Mercedes
authors.initials: M
authors.lastname: Cánovas
authors.forename: Ferran
authors.initials: F
authors.lastname: Torres
authors.forename: Gema
authors.initials: G
authors.lastname: Domenech
authors.forename: Jesús
authors.initials: J
authors.lastname: Cebrecos
authors.forename: Pilar
authors.initials: P
authors.lastname: Pelagio
authors.forename: Marcela
authors.initials: M
authors.lastname: Manríquez
authors.forename: Gemma
authors.initials: G
authors.lastname: Martínez
authors.forename: Marta
authors.initials: M
authors.lastname: Arcabell
authors.forename: Francesc
authors.initials: F
authors.lastname: Cabré
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001569:Benzodiazepines / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004304:Dosage Forms; D004311:Double-Blind Method; D005260:Female; D006207:Half-Life; D006801:Humans; D008297:Male; D013058:Mass Spectrometry; D000077152:Olanzapine; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D004304:Dosage Forms; D001569:Benzodiazepines; D000077152:Olanzapine