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

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

Plain Language Summary

Simplified for easier understanding

This study looks at how a single dose of febuxostat (80 mg) — a medication used to treat gout by lowering uric acid levels — behaves in the body of healthy volunteers. Researchers want to measure how it is absorbed, processed, and cleared by the body (pharmacokinetics), and how it affects uric acid handling in the kidneys (pharmacodynamics). This type of study is important for understanding the ideal dose and any timing of effect. Participants are healthy adults who take a single tablet and provide blood and urine samples. You may be eligible if: - You are a healthy adult between 18 and 70 years old - You have no history of any chronic disease You may NOT be eligible if: - You have any known chronic medical condition Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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