QT/QTc study conducted in Japanese adult healthy subjects: A novel xanthine oxidase inhibitor topiroxostat was not associated with QT prolongation-Reference-Cited by-同舟云学术

QT/QTc study conducted in Japanese adult healthy subjects: A novel xanthine oxidase inhibitor topiroxostat was not associated with QT prolongation

Published:2013-11-22 Issue:4 Volume:54 Page:446-452
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Sugiyama Atsushi¹²,Hashimoto Hiroya³,Nakamura Yuji¹,Fujita Tomoe⁴,Kumagai Yuji⁴

Affiliation:

1. Department of Pharmacology; Faculty of Medicine; Toho University; Omori-Nishi, Ota-ku Tokyo Japan

2. Yamanashi Research Center of Clinical Pharmacology; Iwasa-cho; Fuefuki Yamanashi Japan

3. Project Development Department; Sanwa Kagaku Kenkyusho Co., Ltd.; Higashisotobori-cho, Higashi-ku Nagoya Aichi Japan

4. Clinical Trial Center; Kitasato University East Hospital; Asamizodai, Minami-ku Sagamihara Kanagawa Japan

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/jcph.226/fullpdf

Reference14 articles.

1. ICH Harmonized Tripartite Guideline The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs E14. Available at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Guideline.pdf

2. The thorough QT study four years after the implementation of the ICH E14 guidance;Darpo;Br J Pharmacol.,2010

3. Experimental designs balanced for the estimation of residual effects of treatments;Williams;Aust J Chem.,1949

4. Pharmacokinetics of a once-daily oral dose of moxifloxacin (Bay 12-8039), a new enantiomerically pure 8-methoxy quinolone;Sullivan;Antimicrob Agents Chemother.,1999

5. Lamotrigine does not prolong QTc in a thorough QT/QTc study in healthy subjects;Dixon;Br J Clin Pharmacol.,2008

Cited by 17 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Appraisal of ICH E14/S7B Q&As adopted in February 2022 using thorough QT/QTc study data for α4-integrin antagonist carotegrast methyl in Japanese healthy subjects;Journal of Pharmacological Sciences;2022-11

2. A Phase I, Randomized, Single-Ascending-Dose, Multiple-Dose, and Food-Effect Trial of the Safety, Efficacy, and Pharmacokinetics of Topiroxostat in Healthy Chinese Participants;BIO Integration;2022-09-05

3. A narrative review of clinical evidence validating the efficacy of topiroxostat in managing hyperuricemia;Indian Journal of Rheumatology;2022

4. Development of an In Vivo Predictive Dissolution Methodology of Topiroxostat Immediate-Release Tablet Using In Silico Simulation;AAPS PharmSciTech;2021-04

5. Development and validation for the quantitative determination of xanthine oxidoreductase inhibitor topiroxostat by LC-MS/MS and its clinico-pharmacokinetic study;Journal of Pharmaceutical and Biomedical Analysis;2020-09