CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 78 enrolled
Drug / intervention
Febuxostat XR 80 mg Capsule F1 +3 moredrug
Likely dose
Febuxostat XR 80 mg Capsule F1from 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.

Search/NCT02504320
NCT02504320Phase 1Completed
CompareCT.gov

A Phase 1, Randomized, Open-Label, Single-Dose, 4-Way Crossover Study to Assess the Relative Bioavailability of Four 80 mg Febuxostat XR Formulations

Takeda·interventional·Posted Jul 21, 2015·Updated Jan 19, 2017

In Brief

A Phase 1 clinical trial evaluating Febuxostat XR 80 mg Capsule F1, Febuxostat XR 80 mg Capsule F2, and 2 other interventions for Healthy Volunteers. Completed, enrolled 78 participants across 1 site.

Detailed Summary

This study will assess the relative bioavailability, safety and tolerability following administration of 80 mg single oral doses of 4 febuxostat extended release (XR) formulations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 21, 2015
Enrollment StartAug 1, 2015
Primary CompletionSep 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 10.9 years ago

Interventions

Febuxostat XR 80 mg Capsule F1drug

Febuxostat extended-release (XR) capsules formulation 1

Febuxostat XR 80 mg Capsule F2drug

Febuxostat XR capsules formulation 2

Febuxostat XR 80 mg Capsule F3drug

Febuxostat XR capsules formulation 3

Febuxostat XR 80 mg Capsule F4drug

Febuxostat XR capsules formulation 4