Bioequivalence Study of 2 Sizes of SHR4640 Tablets Orally in Healthy Subjects

Inclusion criteria

• Able and willing to provide a written informed consent.
• 18 years to 45 years (inclusive).
• Body weight should above 45 kg, and body mass index should be between 19 and 28 kg/m2 (inclusive).
• The physical examination, vital signs, laboratory examination and electrocardiogram are not abnormal or abnormal but with no clinical significance.

Exclusion criteria

• Pregnant or nursing women.
• No birth control 1 weeks before screening or until one week after SHR4640 administration.
• Average daily alcohol consume more than 14g for female or more than 28g for male within 1 month before screening, or baseline alcohol screening is positive.
• Smokers (average daily smoking of 5 cigarettes or more in the 3 months before screening).
• Subject with a history of substance abuse and drug abuse.
• The investigators determined that other conditions were inappropriate for participation in this clinical trial.
• sUA level ≥480 μmol/L.
• eGFR < 90 mL/min/1.73 m2.
• Positive result for human immunodeficiency virus (HIV), hepatitis C virus antibody, or syphilis antibody, or hepatitis B surface antigen.
• 12-lead electrocardiogram (ECG) showed abnormal and clinically significant.
• Cardiovascular, neuropsychiatric, respiratory, digestive tract, endocrine and other systemic diseases within 1 year before screening, which were judged to be serious by the investigators.
• History of hypersensitivity to SHR4640 or its analogues.
• History or suspected crystals or stones in the urinary system during the screening period of B-ultrasound.
• History of been diagnosed with acute kidney injury in the past or screening period.
• Had undergone major surgery within 3 months prior to screening, or have not recovered from surgery, or plan major surgery during the study.
• Blood donation within 1 month before screening; Or patients with trauma or major surgical procedures who donated blood or lost blood > 400 mL in the 3 months prior to screening.
• Has unsuitable venous for blood sampling.
• Received the last dose of a study drug (or treatment with a medical device) within 3 months or 5 T1/2 (whichever is longer) of the screening or are currently participating in another study of a study drug (or medical device).
• Have received or been exposed to other live vaccines or live attenuated vaccines within 3 months prior to Day 1, or who plan to receive live vaccines or live attenuated vaccines during the study.
• Consumes grapefruit and/or poppy seed within 48 hours before SHR4640 administration.
• Taken any prescription drugs, over-the-counter drugs, herbal medicines or food supplements within 2 weeks before screening.