Healthy Volunteers Clinical Trial
Official title:
A Phase 1, Open-Label, Single Center, Single-Dose, Randomized, 4-Way Crossover Study to Assess the Effect of an Antacid on the Bioavailability of Febuxostat After Oral Administration of a 80 mg Febuxostat Extended-Release (XR) Capsule Formulation
The purpose of this study is to assess the effect of antacid administration, and its timing, on the bioavailability of a single dose of febuxostat extended-release (XR) 80 mg.
The drug being tested in this study is called febuxostat extended-release (XR). Febuxostat
XR is being tested to assess if antacids affect how the drug moves throughout the body. This
study will look at lab safety and side effects in people who take febuxostat XR.
This cross-over study will enroll approximately 36 patients. Participants will be randomly
assigned to one of four treatment sequences. All participants will receive the following
study medications by the end of the study:
- Febuxostat XR 80 mg capsules
- Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium
Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent
All participants will be administered one dose of one or both of the study medications on
Day 1 of four separate study periods.
This single-centre trial will be conducted in the United States. The overall time to
participate in this study is up to 84 days. Participants will make 5 visits to the clinic
including four 4-day periods of confinement to the clinic, 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: Treatment
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