Pharmacokinetics and Bioequivalence of 2 Olanzapine Orally Disintegrating Tablet Products in Healthy Chinese Subjects Under Fed and Fasting Conditions.

To assess the bioequivalence of two 5-mg olanzapine orally disintegrating tablet (ODT) products, 2 randomized, open-label, single-dose, 2-way crossover studies were carried out under fasting or fed conditions. Blood samples were collected at scheduled times according to the study protocol. Statistical analysis of area under the concentration-time curve from time 0 to 168 hours (AUC _0-t ), area under the curve from time zero to infinity (AUC _0-∞ ), and peak plasma concentration (C _max ) was conducted. Two formulations were considered bioequivalent if the 90% confidence intervals (CIs) of the geometric mean ratios for AUC _0-t, AUC _0-∞ , and C _max were within the range of 0.80-1.25. Adverse events were recorded and evaluated throughout the studies. A total of 48 subjects with 24 in each study completed the 2 studies. In fasted subjects, the 90%CIs for the test product versus the reference product were 97.28%-105.13% for AUC _0-t , 97.57%-105.54% for AUC _0-∞ , and 90.94%-103.97% for C _max . In fed subjects, the 90%CIs for AUC _0-t , AUC _0-∞ and C _max were 99.73%-122.63%, 99.56%-121.75%, and 99.46%-120.46%, respectively. No serious adverse events were reported in the studies. The reference and the test product of 5-mg olanzapine ODT show comparable pharmacokinetic profiles under both fed and fasted conditions and were considered bioequivalent.
(© 2020, The American College of Clinical Pharmacology.)