Single- and Multiple-Dose Pharmacokinetics, Safety and Tolerability of Lurasidone in Healthy Chinese Subjects

Single- and Multiple-Dose Pharmacokinetics, Safety and Tolerability of Lurasidone in Healthy... 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, http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Clinical Drug Investigation Springer Journals

Single- and Multiple-Dose Pharmacokinetics, Safety and Tolerability of Lurasidone in Healthy Chinese Subjects

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Publisher
Springer International Publishing
Copyright
Copyright © 2017 by Springer International Publishing AG
Subject
Medicine & Public Health; Pharmacotherapy; Pharmacology/Toxicology; Internal Medicine
ISSN
1173-2563
eISSN
1179-1918
D.O.I.
10.1007/s40261-017-0546-8
Publisher site
See Article on Publisher Site

Abstract

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,

Journal

Clinical Drug InvestigationSpringer Journals

Published: Jul 10, 2017

References

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