Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-01 @ 5:40 PM
Study NCT ID:
NCT02504320
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2015-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 1, Febuxostat XR Relative Bioavailability Study
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Open-Label, Single-Dose, 4-Way Crossover Study to Assess the Relative Bioavailability of Four 80 mg Febuxostat XR Formulations
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
The drug being tested is this study is febuxostat XR. Four different formulations of febuxostat XR are being tested to see how the drug moves through the body. This study will look at safety and side effects in people who take febuxostat XR.
This cross-over study will enroll approximately 78 patients. Participants will be randomly assigned to 1of 4 sequences which will determine the order of the 4 treatments received:
* Febuxostat XR 80 mg capsule Formulation 1
* Febuxostat XR 80 mg capsule Formulation 2
* Febuxostat XR 80 mg capsule Formulation 3
* Febuxostat XR 80 mg capsule Formulation 4
Participants will take 1 dose on Day 1 with a washout period between each period.
This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 80 days. Participants will make multiple visits to the clinic including a period of confinement, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.
This cross-over study will enroll approximately 78 patients. Participants will be randomly assigned to 1of 4 sequences which will determine the order of the 4 treatments received:
* Febuxostat XR 80 mg capsule Formulation 1
* Febuxostat XR 80 mg capsule Formulation 2
* Febuxostat XR 80 mg capsule Formulation 3
* Febuxostat XR 80 mg capsule Formulation 4
Participants will take 1 dose on Day 1 with a washout period between each period.
This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 80 days. Participants will make multiple visits to the clinic including a period of confinement, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1168-1117 | OTHER | WHO | View |