This is a open-Label, Within-Subject Drug-Drug Interaction Study of ABP-671 Added to Stable Allopurinol Therapy in Gout Patients. Pharmacokinetic (PK) interaction between ABP-671 and Allopurinol will be evaluated in participants who are on stable Allopurinol therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
All subjects undergo three sequential 7-day periods: Period 1 (Day 1-7): Allopurinol； Period 2 (Day 1-7): Allopurinol Plus ABP-671； Period 3 (Day 1-7): ABP-671；
Wakefield Clinical Research
Cary, North Carolina, United States
Maximum plasma concentration (Cmax) of allopurinol
Maximum observed plasma concentration (Cmax) of allopurinol following administration of allopurinol alone and in combination with ABP-671 at steady state.
Time frame: Base line, through Day1, Day 7,Day8,D14,D15,D21
Area under the plasma concentration-time curve over the dosing interval (AUC) of allopurinol
Area under the plasma concentration-time curve over the dosing interval (AUC) of allopurinol following administration of allopurinol alone and in combination with ABP-671 at steady state.
Time frame: Base line, through Day1, Day 7,Day8,D14,D15,D21
Maximum plasma concentration (Cmax) of ABP-671
Maximum observed plasma concentration (Cmax) of ABP-671 when administered with allopurinol and following a post-combination ABP-671 alone period.
Time frame: Though Day7,Day8,Day14,Day15,Day21
Area under the plasma concentration-time curve over the dosing interval (AUC) of ABP-671
Area under the plasma concentration-time curve over the dosing interval (AUC) of ABP-671 when administered with allopurinol and following a post-combination ABP-671 alone period.
Time frame: Though Day7,Day8,Day14,Day15,Day21
Incidence of treatment-emergent adverse events (TEAEs)
Number and percentage of participants experiencing treatment-emergent adverse events.
Time frame: Through study completion, an average of 51 days
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