A single-center, open-access study to evaluate drug interactions between XNW3009, febuxostat, and colchicine in patients with gout
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Colchicine0.5 mg Oral Tablet Day-7\~Day25 qd;Febuxostat 40 mg Oral Tablet Day1 and Day14 qd;XNW3009 0.5 mg Oral Tablet Day8 and Day21 qd
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
RECRUITINGObserved maximum concentration at steady state (Cmax,ss)
To evaluate the maximum concentration at steady state of oral XNW3009 tablets, febuxostat, and colchicine in patients with gout
Time frame: 100 days
Observed area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
To evaluate the AUCss of oral XNW3009 tablets, febuxostat, and colchicine in patients with gout
Time frame: 100 days
Time to Maximum Serum Concentration (Tmax)
To evaluate the Tmax of oral XNW3009 tablets, febuxostat and colchicine in patients with gout
Time frame: 100 days
Mean Terminal Phase Half-life (t1/2)
To evaluate the t1/2 of XNW3009 tablets, febuxostat and colchicine in gout patients
Time frame: 100 days
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
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Time frame: 100 days
Serum or urine Uric Acid Level
Change in Serum or urine Uric Acid Level
Time frame: 100 days
Serum or urine Creatinine
Change in Serum or urine Creatinine
Time frame: 100 days
Number of Participants With Clinically Significant Laboratory Test Abnormalities
Investigator judged clinical significance of laboratory test abnormalities.
Time frame: 100 days