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Comparative Fasting Bioavailability of Two Febuxostat Formulations in Healthy Male Chinese Volunteers: An Open-Label, Randomized, Single-Dose, Two-Way Crossover Study

Comparative Fasting Bioavailability of Two Febuxostat Formulations in Healthy Male Chinese Volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TTRCC-13003760
Enrollment
Unknown
Registered
2013-11-06
Start date
2013-11-11
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

A:1st period, reference formulation-80mg
2nd period, test, 80mg
B:1st period, test formulation-80mg
2nd period, reference, 80mg

Sponsors

First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Male 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

MeasureTime frame
AUC0-t (AUCall);AUC0-8 (AUCINF_obs);Cmax;Tmax;T1/2 (HL_Lambda_z);Ke;90%Confidence Interval;—

Contacts

Public ContactShentu Jianzhong

First Affiliated Hospital, College of Medicine, Zhejiang University

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

Outcome results

None listed

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