Healthy Volunteers Clinical Trial
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
This study will assess the bioavailability, safety and tolerability following administration of 80 mg single oral doses of 4 febuxostat extended release (XR) formulations.
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 76 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-centre 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.
;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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