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 (AUC0‐t), area under the curve from time zero to infinity (AUC0‐∞), and peak plasma concentration (Cmax) was conducted. Two formulations were considered bioequivalent if the 90% confidence intervals (CIs) of the geometric mean ratios for AUC0‐t, AUC0‐∞, and Cmax 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 AUC0‐t, 97.57%‐105.54% for AUC0‐∞, and 90.94%‐103.97% for Cmax. In fed subjects, the 90%CIs for AUC0‐t, AUC0‐∞ and Cmax 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.