None listed
Conditions
Interventions
Single dose - Trial group A1:ND-003 tablets 20mg size two pieces
Single dose - Control A1:placebo 20mg size two pieces
Single dose - Trial group A2:ND-003 tablets 20mg size four pieces
Single dose - Control A2:placebo 20mg size four pieces
Single dose - Trial group A3:ND-003 tablets 20mg size three pieces, 100mg size one piece
Single dose - Control A3:placebo 20mg size three pieces, 100mg size one piece
Single dose - Trial group A4:ND-003 tablets 20mg size two pieces, 100mg size two pieces
Single dose - Control A4:placebo 20mg size two pieces, 100mg size two pieces
Single dose- Trial group A5:ND-003 tablets 100mg size three pieces
Single dose- Control A5:placebo 100mg size three pieces
Multiple dosing- Trsil group B1:pending
Multiple dosing- Control B1:pending
Multiple dosing- Trsil group B2:pending
Multiple dosing- Control B2:pending
Multiple dosing- Trsil group B3:pending
Multiple dosing- Control B3:pending
K-C group:The first cycle was given on an empty stomach, and the second cycle was given after meals
C-K group:The first cycle was given after meals, and the second cycle was given on an empty stomach
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers, both male and female, of which single-sex volunteers shall not be less than one-third of the total number of cases, and volunteers of the same sex shall be replaced in case of replacement; 2. Age: 18 ~ 45 years old, the age difference between volunteers in the same dose group is not more than 10 years old; 3. Weight: male =50kg, female =45kg, 19=BMI=26 (BMI= weight (kg)/height 2 (m2)); 4. Comprehensive health examination is passed: vital signs, physical examination, routine hematuria, blood pregnancy, blood glucose, blood lipids, blood electrolytes, hepatitis B surface antigen, liver and kidney function, hepatitis C, HIV and syphilis antibody test, electrocardiogram, nicotine, urine drug screening, alcohol breath test, abdominal B-ultrasound, chest X-ray examination, etc., no abnormalities or abnormalities have no clinical significance; 5. Before participating in the study, have a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential dangers of the trial, and voluntarily participate in this clinical trial, can communicate well with the investigators, comply with the requirements of the entire study, and have the ability to understand and sign the written informed consent.
Exclusion criteria
Exclusion criteria: Volunteers who meet one of the following conditions are not eligible for this study: 1. Participants in any other clinical trial within three months prior to the trial; 2. (Consultation) Have any disease that may affect the safety of the trial or the process of the drug in vivo, including but not limited to: Previous or existing diseases of the heart, liver, kidney, endocrine, digestive, immune and respiratory systems (especially cardiovascular disease including those at risk for cardiovascular disease, any gastrointestinal disease that affects drug absorption (e.g. symptoms of irritable bowel syndrome, history of inflammatory bowel disease), active pathological bleeding (e.g. peptic ulcer), urticaria, epilepsy, allergic rhinitis) Eczema dermatitis, asthma, active pulmonary tuberculosis, etc.; 3. (Consultation) Allergy: If there is a history of drug, food allergy or skin allergy; 4. (Inquiry) Any drug that inhibits or induces liver metabolism of the drug in the 28 days prior to the use of the study drug (common liver enzyme inducers: barbiturates such as phenobarbital, carbamazepine, aminomide, grofulvin, methylaminopropyl, phenytoin, Grumette, rifampin, dexamethasone; Common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamide); 5. People who have used any medicine (including Chinese herbal medicine) and health care products within 14 days before the first dose; 6. (Consultation) Those who have special requirements for food and cannot comply with a unified diet (such as intolerance to standard meals, etc.); 7. (Consultation) can not tolerate venous puncture, and/or have a history of fainting blood and fainting needles; 8. (Consultation) people who drink excessive tea, coffee or caffeinated beverages (more than 8 cups a day, 1 cup =250mL) in the past; Or study within 48 hours before the first dose, intake of any food or drink containing caffeine (such as coffee, strong tea, chocolate, etc.) and other special diet affecting drug absorption, distribution, metabolism, excretion; 9. (consultation) previous alcohol abuse (i.e., more than 28 standard units per week for men and 21 standard units per week for women (1 standard unit contains 14 grams of alcohol, such as 360 mL beer or 45mL spirits with 40% alcohol or 150 ml wine); Or regular alcohol consumption (more than 14 standard units per week) in the 6 months prior to the trial; Or study use within 24 hours before first dosing Consume any products containing alcohol; 10. (Consultation) People who have donated blood or suffered heavy bleeding (greater than 450 mL) within 3 months before the first dose of the study, or who plan to donate blood or blood components during the study period or within 3 months after the end of the study; 11. (Consultation) Acute illness occurs during the pre-study screening stage or prior to investigational medication; 12. (Consultation) Patients who have taken food or drink containing enzymes that can induce or inhibit liver metabolism (such as grapefruit, mango, dragon fruit, grape juice, orange juice and other flavonoid or citroside rich compounds) within 24 h before the first administration of the study; 13. (Consultation) Patients who have undergone surgery within three months prior to the screening period or who plan to undergo surgery during the study period; 14. (Consultation) Have a history of drug use; A history of drug abuse; 15. (Consultation) Patients who smoked more than 5 cigaret
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood concentration;urine drug level; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fecal concentration; | — |
Countries
China
Contacts
Public ContactShi shaojun
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed