GoutHyperuricemia
Conditions
Interventions
Tininurad Tablets:Tininurad Tablets
QD, 40mg
Duration:1d/7d
Tainingnade blank tablet:Tainingnade blank tablet
QD, 40mg
Duration:1d/7d
Sponsors
Beijing hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Adult male or female subjects aged 18–45 years (inclusive) at screening, based on the date of signing the informed consent form (ICF). 2.Body mass index (BMI = weight[kg]/height[m]²) between 18.0 and 28.0 kg/m² (inclusive), with male subjects weighing =50 kg and female subjects weighing =45 kg. 3.No clinically significant abnormalities in vital signs, physical examination, laboratory tests (except serum uric acid), 12-lead ECG, chest X-ray, or urinary system ultrasound during screening. 4.Subjects of childbearing potential must agree to use medically approved contraception (e.g., intrauterine device, oral contraceptives, or condoms; see Appendix 1 for details) during the trial and for 3 months after trial completion, with no plans to donate sperm/eggs during this period. 5.Serum uric acid levels from two measurements within 28 days prior to randomization must both meet the diagnostic criteria for hyperuricemia (uric acid >420 µmol/L). 6.Subjects must fully understand the trial’s purpose, procedures, potential risks, and voluntarily sign the ICF, demonstrating compliance with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Acute gouty arthritis attack within 1.2 × upper limit of normal (ULN), and/or total bilirubin >1.2 × ULN. 10. Estimated glomerular filtration rate (eGFR) 5 cigarettes/day) within 3 months before screening or unwillingness to abstain from smoking/nicotine products during the study. 18. Alcohol intake >14 units/week (1 unit = 360 mL beer, 45 mL 40% spirits, or 150 mL wine) within 6 months before screening, positive alcohol breath test at baseline, or unwillingness to abstain from alcohol during the study. 19. Unwillingness to abstain from caffeinated beverages (e.g., tea, coffee) from 24 hours before the first dose until the end of the study. 20. Positive for HIV antibody, hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody (TP-Ab). 21. History of unexplained syncope, cardiac arrest, unexplained arrhythmia, torsades de pointes, structural heart disease, or family history of long QT syndrome. 22. Investigator’s judgment of unsuitability for participation due to scientific, compliance, or safety concerns. 23. Close relationship with the research site (e.g., immediate family member of investigator or site staff).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AEs);Laboratory indicators (complete blood count, blood biochemistry, urinalysis, coagulation tests);12-Lead Electrocardiogram (ECG) Assessments data;Vital Signs;Physical Examination;Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) Parameters;Serum Uric Acid (sUA);Urinary Uric Acid (uUA); | — |
Countries
China
Contacts
Public ContactShi AiXin
Beijing hospital
Outcome results
None listed