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Authors
Liu, Yun https://orcid.org/0000-0001-9214-413X
Chen, Qian https://orcid.org/0000-0001-9834-6912
Sun, Hui
Cai, Cuiyuan
Kawamura, Kotomi
Kokan, Rieko
Nomoto, Maiko https://orcid.org/0000-0002-8760-1305
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Clinical Trials BETA
Clinical trials referenced in this document:
nct05278676 at ClinicalTrials.govDocuments that mention this clinical trial
A Single- and Multiple-Dose Study to Characterize the Pharmacokinetics and Safety of Dotinurad in Healthy Chinese Adults
https://doi.org/10.1007/s40261-025-01496-x
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Funding
Funding for this research was provided by:
Eisai
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Article History
Received: 21 February 2025
Accepted: 30 September 2025
First Online: 19 October 2025
Declarations
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: Y. Liu and Q. Chen have received honoraria (investigator fees) from Eisai Co., Ltd. H. Sun is an employee of Eisai China Inc. C. Cai, K. Kawamura, R. Kokan, and M. Nomoto are employees of Eisai Co., Ltd.
: The protocol was approved by the ethics committee of Shanghai Xuhui Central Hospital (approval number 2022-002). The study was conducted in accordance with the Declaration of Helsinki and Chinese Good Clinical Practice guidelines and all applicable regulations. All study participants provided written informed consent. This study was registered at ClinicalTrials.gov under the identifier number NCT05278676.
: Written consent for publication was obtained from all study participants.
: The data that support the findings of this study are available from the corresponding author upon reasonable request.
: All analyses were conducted using standard software (SAS 9.4 and Phoenix WinNonlin TM 8.3.5). No custom code was used in this study, so code availability is not applicable.
: Conceptualization and methodology: Cuiyuan Cai, Kotomi Kawamura, Maiko Nomoto; investigation: Yun Liu, Qian Chen, Hui Sun, Rieko Kokan; formal analysis: Yun Liu, Qian Chen, Cuiyuan Cai, Maiko Nomoto; Writing—original draft and writing—review and editing: all authors. All authors read and approved the final version and agreed to submit the article for publication. All authors also confirm accountability for the accuracy and integrity of the work.
