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.
1. Is a healthy adult male or female aged 18 to 55 years, inclusive, by check-in (Day-1
of Period 1)
2. Weighs at least 50 kg (110 pounds), and has a body mass index (BMI) between 18.0
kg/m^2 to 30 kg/m^2, inclusive at Screening.
3. Has estimated glomerular filtration rate ≥90 mL/min
Any participant who meets any of the following criteria will not qualify for entry into
1. Has received any investigational compound within 30 days prior to the first dose of
2. Has received febuxostat in a previous clinical study or as a therapeutic agent.
3. Has a known hypersensitivity to any xanthine oxidase inhibitor, xanthine compounds or
any component of the formulation of febuxostat tablets (see Package Insert) or to
4. Has a known hypersensitivity to aluminum, magnesium hydroxide, or any component of
the formulation of antacid (Maalox Advanced Regular Strength or equivalent) (see
5. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain
from alcohol and drugs throughout the study. If female, the participant is pregnant
or lactating or intending to become pregnant before, during, or within 30 days after
participating in this study; or intending to donate ova during such time period.
6. Has current or recent (within 6 months) gastrointestinal disease that would be
expected to influence the absorption of drugs (ie, a history of malabsorption,
esophageal reflux, peptic ulcer disease, erosive esophagitis frequent [more than once
per week] occurrence of heartburn, or any surgical intervention [eg,