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Phase 1, Febuxostat XR Relative Bioavailability Study

NCT02504320 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2017-01-19

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Febuxostat XR 80 mg Capsule F1

Febuxostat extended-release (XR) capsules formulation 1

DRUG

Febuxostat XR 80 mg Capsule F2

Febuxostat XR capsules formulation 2

DRUG

Febuxostat XR 80 mg Capsule F3

Febuxostat XR capsules formulation 3

DRUG

Febuxostat XR 80 mg Capsule F4

Febuxostat XR capsules formulation 4

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2015-09-30
Completion
2015-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02504320 on ClinicalTrials.gov