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 C_max values were tested for bioequivalence based on the ratios of the geometric means (test/reference). t_max was analysed nonparametrically. The 90% confidence intervals of the geometric mean values for the test/reference ratios for AUC_0−t and C_max 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.

Key words

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

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