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.
|Publication status||Published - 11 Mar 2011|
- Atypical antipsychotic
- CAS 132539-06-1
- Healthy volunteers
- Olanzapine, tablet