Bioequivalence of Blonanserin Tablets Under Fasting and Fed Conditions in Healthy Chinese Subjects

Abstract

AbstractBlonanserin is a novel oral antischizophrenic drug. Under fasting (n = 50) and fed (n = 60) conditions, this study compared the bioequivalence of the generic blonanserin tablet with the reference blonanserin tablet. In this single‐center, randomized, open‐label, 2‐period, 2‐sequence, crossover study, 110 patients were randomly given a 4‐mg dose of either the test or reference blonanserin tablet with a 14‐day washout period. Blood samples were taken before performing and up to 72 hours following. A validated high‐performance liquid chromatography‐tandem mass spectrometry technique was used to measure the levels of blonanserin in plasma. Safety was evaluated throughout the study. The study found no significant differences in the maximum observed drug concentration in the plasma (Cmax), the area under the plasma concentration‐time curve from time 0 to the last sampling time (AUC0‐t), and the area under the plasma concentration‐time curve from time 0 to infinity (AUC0‐∞) between the 2 blonanserin formulations. The 90% confidence intervals of the geometric mean ratio of the test/reference formulations for Cmax, AUC0‐t, and AUC0‐∞ were within the 80%‐125% limit. Food dramatically raised blonanserin exposure, and also significantly prolonged the lag time of absorption. No serious adverse events occurred. These results indicate that the 2 blonanserin formulations were bioequivalent and well tolerated in healthy Chinese subjects. In clinical treatment, it is necessary to consider the food effect of blonanserin.