Evidence map›Paper›PMID 41111126›Full record

ArticleClinical drug investigation2025

A Single- and Multiple-Dose Study to Characterize the Pharmacokinetics and Safety of Dotinurad in Healthy Chinese Adults.

Yun Liu, Qian Chen, Hui Sun, Cuiyuan Cai, Kotomi Kawamura, Rieko Kokan, Maiko Nomoto

Registry-linked trialAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical drug investigation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05278676 (A Single and Multiple Dose Pharmacokinetic Study of Dotinurad in Chinese Healthy Subjects), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05278676 phase1completednot on this map

A Single and Multiple Dose Pharmacokinetic Study of Dotinurad in Chinese Healthy Subjects

TypeinterventionalSponsorEisai Co., Ltd.Ran2022 to 2022Enrolled26ConditionsHealthy VolunteersArmsDotinurad
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Yun LiuPhase 1 Clinical Research Unit, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.ORCID http://orcid.org/0000-0001-9214-413X
Qian ChenPhase 1 Clinical Research Unit, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.ORCID http://orcid.org/0000-0001-9834-6912
Hui SunEisai China Inc., Beijing, China.
Cuiyuan CaiEisai Co., Ltd., Koishikawa 4-6-10, Bunkyo-ku, Tokyo, 112-8088, Japan.
Kotomi KawamuraEisai Co., Ltd., Koishikawa 4-6-10, Bunkyo-ku, Tokyo, 112-8088, Japan.
Rieko KokanEisai Co., Ltd., Koishikawa 4-6-10, Bunkyo-ku, Tokyo, 112-8088, Japan.
Maiko NomotoEisai Co., Ltd., Koishikawa 4-6-10, Bunkyo-ku, Tokyo, 112-8088, Japan. m-nomoto@hhc.eisai.co.jp.ORCID http://orcid.org/0000-0002-8760-1305

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesDotinurad is a selective uricosuric drug for patients with gout with hyperuricemia. To our knowledge, this is the first study to evaluate the pharmacokinetics (PK) of dotinurad, following single and multiple oral doses in healthy Chinese adults.

methodsThis single-center, open-label, parallel group, phase 1 study had 3 cohorts: A (1-mg single dose), B (single and multiple doses of 4 mg once daily for 7 days), and C (10-mg single dose). Dotinurad was administered on an empty stomach. Healthy nonsmoking Chinese adults aged 18-45 years with body mass index 19-24 k/m

resultsIn total, 26 subjects were included. After single oral doses of 1, 4, and 10 mg, mean ± standard deviation (SD) plasma dotinurad concentration reached maximum observed plasma concentration (C

conclusionSingle- and multiple-dose PK of dotinurad in healthy Chinese adults showed rapid absorption, rapid elimination, linear PK, and no accumulation with once-daily dosing. Dotinurad was well-tolerated during the 7-day treatment course.

trial registrationClinicalTrials.gov: NCT05278676.

Indexed as

TriazolesUricosuric AgentsAdministration, OralAdolescentAdultBenzothiazolesChinaDose-Response Relationship, DrugDrug Administration ScheduleEast Asian PeopleFemaleHealthy VolunteersHumansMaleMiddle AgedYoung AdultBenzothiazolesdotinuradTriazolesUricosuric Agents

Identifiers

PMID41111126
PMCPMC12669303

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.