Clinical Trial for Effect of TQB3616 Capsule on Pharmacokinetics in Healthy Adult Subjects

Inclusion criteria

• 1 Sign the informed consent form before the trial and fully understand the content, process and possible adverse reactions of the trial;
• 2 Be able to complete the study according to the requirements of the study protocol;
• 3 Subjects aged 18 to 65 years (including 18 and 65 years);
• 4 Body mass index (BMI) ≥ 18 and ≤ 28 kg/m2, and male body weight ≥ 50 kg Female body weight ≥ 45 kg;
• 5 Health condition: no mental disorders, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities;
• 6 Subjets had no plans to become pregnant and voluntarily took effective contraceptive measures from 2 weeks before dosing to at least 6 months after the last dose of study drug.

Exclusion criteria

• 1 Patients with a history of neuropsychiatric, respiratory, cardiovascular, gastrointestinal, hemolymphatic, hepatic or renal insufficiency, endocrine, musculoskeletal system disease or other diseases, which may affect drug metabolism or safety as judged by the investigator;
• 2 Allergic constitution or previous history of two or more kinds of food or drug allergy;
• 3 Hyperactive/venous thrombotic events within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism;
• 4 Patients with multiple factors affecting oral drugs (such as inability to swallow, gastrointestinal diseases);
• 5 Taking any prescription drugs, over-the-counter drugs, vitamin products or herbal medicines within 1 month before taking the study drug;
• 6 Administration of CYP3A4 inhibitors or inducers within 1 month before screening or before study drug;
• 7 Taking special diet (including grapefruit, etc.) or strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc. within 14 days before screening;
• 8 Abnormal and clinically significant laboratory findings during the screening period;
• 9 Blood donation or significant blood loss (> 450 mL) within 3 months prior to administration of study drug;
• 10 Participated in any drug clinical trial within 3 months before taking the study drug;
• 11 Smoking more than 5 cigarettes per day within 3 months before the trial;
• 12 Positive breath alcohol test or history of alcoholism (14 units of alcohol per week: 1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine);
• 13 Drug screening positive or drug use 3 months before the trial;
• 14 Inability to tolerate venipuncture for blood sampling or poor vascular status;
• 15 Subjets cannot complete the trial due to personal reasons;
• 16 Other conditions considered inappropriate by the investigator.