Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia

A Randomized, Double-Blind, Crossover, Pharmacodynamic and Pharmacokinetic Drug Interaction Study of Tranilast in Combination With Febuxostat Compared With Tranilast Alone and Febuxostat Alone in Healthy Subjects With Hyperuricemia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00995618

Enrollment

Registered

2009-10-15

Start date

2009-09-30

Completion date

2010-04-30

Last updated

2011-01-06

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

Conditions

Gout, Hyperuricemia

Keywords

Gout, Hyperuricemia

Brief summary

This is a randomized, double-blind, 3-period crossover phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on febuxostat pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of febuxostat on tranilast PK and PD as measured by reduction in serum uric acid levels.

Interventions

DRUGTranilast

Tranilast tablets, 300 mg, QD

DRUGFebuxostat

Febuxostat Tablets, 40 mg, QD

DRUGCombination - Tranilast and Febuxostat

Tranilast, 300 mg QD; Febuxostat, 40 mg QD

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Male or female, aged 18 to 70 * Subjects with hyperuricemia who are otherwise healthy

Exclusion criteria

* Pregnant or nursing * Known history of gout * Clinically significant infection at Screening * Known sensitivity to tranilast or febuxostat

Design outcomes

Primary

Measure	Time frame
Mean decrease in serum uric acid levels	Seven days

Secondary

Measure	Time frame
Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, febuxostat and combination	7 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026