Pharmacokinetics and Tolerability of Febuxostat Tablets after Oral Administration in Healthy Chinese Volunteers: A Randomized, Open-Label, Single- and Multiple-Dose Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TTRCC-14005168

Enrollment

Unknown

Registered

2014-09-02

Start date

2013-05-09

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Interventions

40-mg dose:administer febuxostat 40mg as a single dose (day1) and multiple doses (days 4–9)

80-mg dose:administer febuxostat 80mg as a single dose (day1) and multiple doses (days 4–9)

120-mg dose:received a single dose of 120mg febuxostat

Eligibility

Sex/Gender

Male

Age

22 Years to 30 Years

Inclusion criteria

Inclusion criteria: Chinese volunteers aged 18 to 40 years with body mass index (BMI) between 19 and 25 kg/m2 were eligible for participation. Each volunteer was required to provide written informed consent for participation before the study.

Exclusion criteria

Exclusion criteria: Exclusion criteria included known hypersensitivity to any ingredient in this tablet; the presence of heart, kidney, neurologic, or metabolic disease; any acute or chronic disease; and the use of other drugs within 14 days before or during the trial.

Design outcomes

Primary

Measure	Time frame
Cmax;AUC0-t;AUC0-infinity;MRT0-t;t1/2z;Tmax;CLz/F;Vz/F;AUCss;Css_max;Css_min;Cav;DF;	—

Contacts

Public ContactJianzhong Shentu

stjz@zju.edu.cn+86 0571-87236560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026