Phase 1, Febuxostat XR Relative Bioavailability Study
Condition: Healthy Volunteers
Intervention: Febuxostat XR 80 mg Capsule F1; Febuxostat XR 80 mg Capsule F2; Febuxostat XR 80 mg Capsule F3; Febuxostat XR 80 mg Capsule F4
Intervention description: Febuxostat extended-release (XR) capsules formulation 1; Febuxostat XR capsules formulation 2; Febuxostat XR capsules formulation 3; Febuxostat XR capsules formulation 4
Intervention MeSH terms: Febuxostat
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator, the participant is capable of understanding and
             complying with protocol requirements.

          2. The participant or, when applicable, the participant's legally acceptable
             representative signs and dates a written, informed consent form and any required
             privacy authorization prior to the initiation of any study procedures including
             requesting that a participant fast for any laboratory evaluations.

          3. Is a healthy male or female and aged 18 to 55 years, inclusive, at the time of
             informed consent and first study medication dose.

          4. Weighs at least 50.0 kg and has a body mass index (BMI) from 18.0 to 30.0 kg/m2,
             inclusive at Screening.

          5. A male participant who is nonsterilized and sexually active with a female partner of
             childbearing potential agrees to use adequate contraception from signing of informed
             consent throughout the duration of the study and for 30 days after the last dose.

          6. A female participant of childbearing potential who is sexually active with a
             nonsterilized male partner agrees to use routinely adequate contraception from signing
             of informed consent,

          7. Is willing to refrain from strenuous exercise from Day -1 of Period 1 until Study Exit
             (Day 3 of Period 4).

          8. Has estimated glomerular filtration rate (eGFR) ≥90 mL/min at Screening and Check-in
             (Day -1 of Period 1).

        Exclusion Criteria:

          1. Has received any investigational compound within 30 days prior to the first dose of
             study medication.

          2. Has received febuxostat in a previous clinical study or as a therapeutic agent.

          3. Is an immediate family member, study site employee, or is in a dependant relationship
             with a study site employee who is involved in the conduct of this study.

          4. Has uncontrolled, clinically significant (CS) disease or other abnormality, which may
             impact the ability of the participant to participate or potentially confound the study
             results.

          5. Has a known hypersensitivity to any component of the formulation of XO inhibitors,
             xanthine compounds, caffeine, or any component of the formulation of febuxostat
             capsules.