A open label multi-center 3-period multidose, PK/PD and drug-drug interaction (DDI) study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of 7 days of treatment with two doses of dotinurad monotherapy, and to evaluate the effect of dotinurad, as monotherapy and in combination with allopurinol, versus allopurinol monotherapy, on the PK of each, and to assess the additive PD effects on serum uric acid and urinary urate excretion in U.S. patients with gout and hyperuricemia
Age range
18 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Peak Plasma Concentrations (Cmax) - Dotinurad PK Analysis
Timeframe: Day 7
Area Under the Plasma Concentration Versus Time Curve (AUC 0-last) - Dotinurad PK Analysis
Timeframe: Day 7
Area Under the Plasma Concentration Versus Time Curve (AUC 0-τ) - Dotinurad PK Analysis
Timeframe: Day 7
Time to Maximum Plasma Concentration (Tmax) - Dotinurad PK Analysis
Timeframe: Day 7
Terminal Half-life (T1/2) - Dotinurad PK Analysis
Timeframe: Day 7
Peak Plasma Concentration (Cmax) - Dotinurad DDI PK Analysis
Timeframe: Day 7 and Day 14
Area Under the Plasma Concentration Versus Time Curve (AUC 0-last) - Dotinurad DDI PK Analysis
Timeframe: Day 7 and Day 14
Area Under the Plasma Concentration Versus Time Curve (AUC 0-τ) - Dotinurad DDI PK Analysis
Timeframe: Day 7 and Day 14
Terminal Half-life (T1/2) - Dotinurad DDI PK Analysis
Timeframe: Day 7 and Day 14