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.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001346369

Enrollment

Registered

2017-09-25

Start date

2016-07-05

Completion date

2021-03-08

Last updated

2020-12-07

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

Conditions

None listed

Brief 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.

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 hours post dose administration. No adherence assessment is required in this single dose study.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy subjects

Exclusion criteria

Subject with a history of any chronic disease.

Outcome results