Clin Drug Investig (2017) 37:861–871 DOI 10.1007/s40261-017-0546-8 ORIGINAL RESEARCH ARTICLE Single- and Multiple-Dose Pharmacokinetics, Safety and Tolerability of Lurasidone in Healthy Chinese Subjects 1 1 1 1 2 • • • • • Chaoying Hu Yijun Wang Rong Song Chen Yu Xiaoyan Luo Jingying Jia Published online: 10 July 2017 Springer International Publishing AG 2017 Abstract (AUC) and C values increased approximately dose max Background and Objective The pharmacokinetics of proportionally. Lurasidone steady state was achieved after lurasidone have been studied in healthy Japanese and 5 days of daily dosing and the accumulation index of the Caucasian subjects, but not in Chinese subjects. The AUC during a dosage interval (AUC ) was 1.25, smaller objective of this study was to evaluate the pharmacoki- than theoretical cumulative coefﬁcient (1.76). Similar netics, safety, and tolerability of oral lurasidone in healthy results were observed for the metabolites (ID-14283, ID- Chinese subjects. 14326, and ID-11614). No severe adverse events (AEs) Methods This single-center, randomized, parallel-group, were observed in the single- or multiple-dose studies and placebo-controlled, and double-blind study evaluated the no subject discontinued from the study due to AEs. The pharmacokinetics, safety, and tolerability of oral lurasidone most common reported AEs were somnolence,
Clinical Drug Investigation – Springer Journals
Published: Jul 10, 2017
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