The purpose of this study is to assess the effect of food on the bioavailability of febuxostat after a single oral dose of 80 mg febuxostat XR and to evaluate the pharmacokinetics (PK) of febuxostat after single oral doses of 40 and 80 mg febuxostat XR.
The drug being tested in this study is called febuxostat extended- release (XR). This study is evaluating the effect of food on how febuxostat-XR moves throughout the body. This study will also look at the side effects and all safety results in people who took the study drug. This 3-way crossover study will enroll approximately 36 participants. Eligible participants will be randomly (by chance) assigned to one of the 3 treatment sequences at 1:1:1 ratio. Sequence defines the order in which participants receive Regimens A (febuxostat XR 80 mg after a high fat meal), B (febuxostat XR 40 mg after fasting) and C (febuxostat XR 80 mg after fasting): Sequence 1: A, B, C Sequence 2: B, C, A Sequence 3: C, A, B The dose in a period and the dose in the subsequent period will be separated by a minimum 7-day washout interval. This single-centre trial will be conducted in the United States. Participants will make multiple visits to the clinic including three 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. .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Febuxostat XR capsules
Unnamed facility
Austin, Texas, United States
Cmax: Maximum Observed Plasma Concentration for Febuxostat XR 80 mg in Fed (Regimen A) and Fasted (Regimen C) States
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Participant blood samples were collected pre-dose and following a single oral dose.
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose
Cmax: Maximum Observed Plasma Concentration for Febuxostat XR 40 mg (Regimen B) and Febuxostat XR 80 mg (Regimen C) in Fasted States
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Participant blood samples were collected pre-dose and following a single oral dose.
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post dose
AUCt: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for Febuxostat XR 80 mg in Fed (Regimen A) and Fasted (Regimen C) States
AUCt is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration. Participant blood samples were collected pre-dose and following a single oral dose.
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose
AUCt: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for Febuxostat XR 40 mg (Regimen B) and Febuxostat XR 80 mg (Regimen C) in Fasted States
AUCt is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUCt) Participant blood samples were collected pre-dose and following a single oral dose.
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose
AUCinf: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Febuxostat XR 80 mg in Fed (Regimen A) and Fasted (Regimen C) States
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AUCinf is a measure of total plasma exposure to the drug from time zero extrapolated to infinity. Participant blood samples were collected pre-dose and following a single oral dose.
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose
AUCinf: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Febuxostat XR 40 mg (Regimen B) and Febuxostate XR 80 mg (Regimen C) in Fasted States
AUCinf is a measure of total plasma exposure to the drug from time zero extrapolated to infinity. Participant blood samples were collected pre-dose and following a single oral dose.
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose