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The primary purpose of this study is to evaluate the pharmacokinetics (PK) of dotinurad following single and multiple oral doses of dotinurad in Chinese healthy male and female participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A Single Dose: Dotinurad | Experimental | Participants will receive dotinurad 1 milligram (mg) (1*1 mg tablet) as a single oral dose after 10-hour fasting on Day 1 in the morning. |
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| Cohort B Multiple Dose: Dotinurad | Experimental | Participants will receive dotinurad 4 mg (2*2 mg tablets) as a single oral dose after 10-hour fasting on Day 1 in the morning. A washout period of 3 days will be maintained after single dose on Day 1 and then participants will receive dotinurad 4 mg (2*2 mg tablets) after 10-hour fasting from Day 4 to Day 10 once daily in the morning. |
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| Cohort C Single Dose: Dotinurad | Experimental | Participants will receive dotinurad 10 mg (5*2 mg tablets) as a single oral dose after 10-hour fasting on Day 1 in the morning. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dotinurad | Drug | Dotinurad oral tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Single-dose Part, Cmax: Maximum Observed Concentration for Dotinurad | Day 1: 0-48 hours post dose | |
| Single-dose Part, Tmax: Time at Which the Highest Drug Concentration Occurs for Dotinurad | Day 1: 0-48 hours post dose | |
| Single-dose Part, t1/2: Terminal Elimination Phase Half-life for Dotinurad | Day 1: 0-48 hours post dose | |
| Single-dose Part, AUC0-t: Area Under the Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration for Dotinurad | Day 1: 0-48 hours post dose | |
| Single-dose Part, AUC0-24h: Area Under the Concentration-time Curve From Zero Time to 24 hours for Dotinurad | Day 1: 0-24 hours post dose | |
| Single-dose Part, AUC0-inf: Area Under the Concentration-time Curve From Zero Time Extrapolated to Infinite Time for Dotinurad | Day 1: 0-48 hours post dose | |
| Single-dose Part, CL/F: Apparent Total Clearance Following Oral Administration for Dotinurad | Day 1: 0-48 hours post dose | |
| Single-dose Part, Vz/F: Apparent Volume of Distribution at Terminal Phase for Dotinurad | Day 1: 0-48 hours post dose | |
| Single-dose Part, kel: Elimination Rate Constant for Dotinurad | Day 1: 0-48 hours post dose |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui District Central Hospital | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41111126 | Derived | Liu Y, Chen Q, Sun H, Cai C, Kawamura K, Kokan R, Nomoto M. A Single- and Multiple-Dose Study to Characterize the Pharmacokinetics and Safety of Dotinurad in Healthy Chinese Adults. Clin Drug Investig. 2025 Dec;45(12):957-966. doi: 10.1007/s40261-025-01496-x. Epub 2025 Oct 19. |
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Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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| ID | Term |
|---|---|
| C000706811 | dotinurad |
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| Single-dose Part, MRT0-t: Mean Residence Time From Zero Time to Time of Last Quantifiable Concentration on Single Dose for Dotinurad | Day 1: 0-48 hours post dose |
| Multiple-dose Part, Css,max: Maximum Observed Concentration at Steady State for Dotinurad | Day 10: 0-72 hours post dose |
| Multiple-dose Part, Css,min: Minimum Observed Concentration at Steady State for Dotinurad | Day 10: 0-72 hours post dose |
| Multiple-dose Part, Css,av: Average Steady-state Concentration for Dotinurad | Day 10: 0-72 hours post dose |
| Multiple-dose Part, tss,max: Time at Which the Highest Drug Concentration Occurs at Steady State for Dotinurad | Day 10: 0-72 hours post dose |
| Multiple-dose Part, t1/2: Terminal Elimination Phase Half-life for Dotinurad | Day 10: 0-72 hours post dose |
| Multiple-dose Part, AUC0-τ: Area Under the Concentration-time Curve Over the Dosing Interval on Multiple Dosing for Dotinurad | Day 10: 0-72 hours post dose |
| Multiple-dose Part, CLss/F: Apparent Total Clearance Following Oral Administration at Steady State for Dotinurad | Day 10: 0-72 hours post dose |
| Multiple-dose Part, Vz/F: Apparent Volume of Distribution at Terminal Phase for Dotinurad | Day 10: 0-72 hours post dose |
| Multiple-dose Part, kel: Elimination Rate Constant for Dotinurad | Day 10: 0-72 hours post dose |
| Multiple-dose Part, MRT: Mean Residence Time for Dotinurad | Day 10: 0-72 hours post dose |
| Multiple-dose Part, Rac(AUC0-24h): Accumulation Ratio for AUC(0-24h) | Day 10: 0-24 hours post dose |
| Multiple-dose Part, Rac(Cmax): Accumulation Ratio for Cmax | Day 10: 0-72 hours post dose |
| Multiple-dose Part, PTF: Peak-trough Fluctuation | Day 10: 0-72 hours post dose |