At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Febuxostat XRdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Open-Label, Single-Center, Randomized, 3-Way Crossover Study to Assess the Effect of Food on the Bioavailability of a Single Oral Dose of 80 mg Febuxostat Extended-Release Formulation and the Pharmacokinetics of a Single Oral Dose of 40 mg and 80 mg Febuxostat Extended-Release Formulation in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Febuxostat XR for Gout. Completed, enrolled 36 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the effect of food on the bioavailability of febuxostat after a single oral dose of 80 mg febuxostat XR and to evaluate the pharmacokinetics (PK) of febuxostat after single oral doses of 40 and 80 mg febuxostat XR.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartFeb 2015
First PostedFeb 2015
Primary CompletionMar 2015
Study CompletionApr 2015
TodayJul 2026
First PostedFeb 27, 2015
Enrollment StartFeb 1, 2015
Primary CompletionMar 1, 2015
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 11.3 years ago
Interventions
Febuxostat XRdrug
Febuxostat XR capsules