cancer
Conditions
Interventions
fast-fed:fast+fed
fed-fast:fed+fast
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Chinese healthy adult subjects aged between 18 and 45 (inclusive), male or female; 2. Female weight >= 45.0 kg, male weight >= 50.0 kg, and body mass index (BMI) between 19.0 and 26.0 kg/m2 (including 19.0 and 26.0 kg/m2); 3. Physical examination, vital signs, laboratory examination (blood routine examination, urine routine examination, blood biochemical examination, blood coagulation function, blood pregnancy, glycosylated hemoglobin, etc.), abdominal B-ultrasound (liver, gallbladder, pancreas, spleen and kidney), chest X-ray (positive position), and 12 lead ECG are normal or abnormal according to the researcher's judgment, without clinical significance; 4. Subjects can take appropriate and effective contraceptive measures from 2 weeks before signing the informed consent form to 6 months after the end of the trial to avoid pregnancy of the subjects or their partners during this period; 5. Subjects voluntarily signed the informed consent form, understood the purpose, process, risk and other information of the trial, and were able to maintain good communication with researchers and comply with the requirements of the clinical trial.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution (allergic to 2 or more substances), or history of allergic diseases (such as urticaria, allergic rhinitis, etc.), or allergic to test drug/excipient ingredients; 2. Diseases with abnormal clinical manifestations occurred or occurring before screening, including but not limited to diseases of nerve/spirit, respiratory system, cardio cerebral vascular system, digestive system (any gastrointestinal disease history affecting drug absorption, distribution, metabolism and excretion), blood and lymphatic system, hepatobiliary system, urinary system, endocrine system and immune system; 3. Dysphagia; 4. Those who have undergone surgery within 3 months before screening, or who plan to undergo surgery during the study period; 5. Blood donation or massive blood loss (>= 400 mL) or blood transfusion/blood products within 3 months before screening, or blood donation during the planned test and within 3 months after the test; 6. Those who cannot tolerate venous puncture or have a history of blood sickness or needle sickness; 7. Those with a history of drug abuse or positive urine drug abuse screening during screening/baseline period; 8. Positive results of hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, treponema pallidum antibody (TP Ab) and human immunodeficiency virus (HIV) antibody tests; 9. Those who have been vaccinated within 28 days before screening or planned to be vaccinated during the trial; 10. Take any prescription drugs, over-the-counter drugs, health products or Chinese herbal medicine within 14 days before screening; 11. Any drugs that inhibit or induce liver drug metabolizing enzymes (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, etc.; inhibitors - SSRI antidepressants, cimetidine, macrolides, nitroimidazoles, verapamil, fluoroquinolones, antihistamines, etc.) were used within 28 days before screening; 12. Those who smoked more than 5 cigarettes a day within 3 months before screening, or could not quit smoking during the trial; 13. Those who have a history of alcoholism within 3 months before screening (drinking more than 14 units of alcohol (1 unit=360 mL of beer or 45 mL of spirits or 150 mL of wine with an alcohol content of 40%) every week, or who have a positive alcohol blood screening during screening/baseline period; 14. Those who have taken special diet (including pitaya fruit, mango, grapefruit, chocolate, high xanthine foods, or drinks containing caffeine and alcohol), or have strenuous exercise, or have significant changes in diet habits within 48 hours before the weekly administration; 15. Those who have special requirements for diet (such as food allergy in high-fat meals) and cannot follow the unified diet; 16. Pregnant or lactating women; 17. Those who have been included in other clinical trials within 3 months before screening; 18. Other subjects judged by the researcher not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma drug concentration; | — |
Countries
China
Contacts
Public ContactHu Wei
The Second Hospital of Anhui Medical University
Outcome results
None listed