Fukase, Hiroyuki
Okui, Daisuke
Sasaki, Tomomitsu
Fushimi, Masahiko
Ohashi, Tetsuo
Hosoya, Tatsuo
Clinical trials referenced in this document:
Documents that mention this clinical trial
Effects of mild and moderate renal dysfunction on pharmacokinetics, pharmacodynamics, and safety of dotinurad: a novel selective urate reabsorption inhibitor
https://doi.org/10.1007/s10157-019-01825-3
Article History
Received: 1 October 2019
Accepted: 20 November 2019
First Online: 10 December 2019
Compliance with ethical standards
:
: Fuji Yakuhin Co., Ltd. (Fuji) the manufacturer of dotinurad sponsored this study. TH was an advisor to Fuji regarding this study and received consultant and manuscript fees. HF was principal investigator to this study and received manuscript fees. The other authors were employees of Fuji.
: The study protocol and informed consent document were reviewed and approved by an institutional review board (CPC Clinical Trial Hospital; Kagoshima, Japan). Informed consent was obtained from all individual participants included in the study. The tests were conducted in compliance with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards, Good Clinical Practice guidelines, and other requirements by regulation. The information in this study was registered with Clinical Trials.gov (ClinicalTrials.gov number: NCT02347046).