RecruitingPhase 2ACTRN12617001346369

Single dose study of febuxostat (80 mg) in healthy subjects.

The pharmacokinetics and pharmacodynamics of a single dose of febuxostat (80 mg) in healthy subjects.

Sponsor

St Vincent's Hospital, Sydney

Enrollment

10 participants

Start Date

Jul 5, 2016

Study Type

Interventional

Conditions

Chronic gout

Summary

Healthy subjects will be administered a single dose of febuxostat (80 mg) to examine the the pharmacokinetic and pharmacodynamic profiles of febuxostat following the administration of a single dose (80 mg). This study will also investigate the effect of a single dose of febuxostat (80 mg) on the renal handling of urate.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Inclusion Criteria1

Healthy subjects

Exclusion Criteria1

Subject with a history of any chronic disease.

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Interventions

Healthy subjects will be orally administered a single dose of febuxostat (80 mg). Urine (total catch) and blood samples will be collected at baseline (before administrating the dose) and for 102 hou

Healthy subjects will be orally administered a single dose of febuxostat (80 mg). Urine (total catch) and blood samples will be collected at baseline (before administrating the dose) and for 102 hours post dose administration. No adherence assessment is required in this single dose study.

Locations(1)

St Vincent's Hospital (Darlinghurst) - Darlinghurst

NSW, Australia

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ACTRN12617001346369