Alzheimer's disease, AD
Conditions
Interventions
Dose Improved by Fibonacci method, dose group is: 5 mg (6 cases), 10 mg (12 cases), 20 mg (12 cases) and 40 mg (12 cases), 80 mg (12 cases), 120 mg (8 cases), 180 mg (8 cases), 240 (6 cases) 8 mg dose
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) male and female (1:1); 2) Aged 18 to 45 years old (including the boundary value); 3) Body weight: The subject's body mass index (BMI) within the range of 18 - 26 kg/m2 (including the boundary value); 4) Subjects who are able to understand and give their signed informed consent before any trial related procedures are performed; 5) The subject can communicate well with the researcher and complete the study in accordance with the research regulations.
Exclusion criteria
Exclusion criteria: 1) Have a clinically meaningful disease or have undergone surgery within 4 weeks before the test; 2) Clearly allergic to this product or any of its accessories (microcrystalline cellulose PH302, mannitol 200SD, hypromellose E5, crospovidone XL-10, silicon dioxide and magnesium stearate); 3) There is any history of serious clinical disease or a history of circulatory, endocrine, neurological or hematological, immunological, psychiatric, and metabolic abnormalities. People with history of epilepsy and convulsions; 4) Have had gastrointestinal tract, liver and kidney diseases that can affect the absorption or metabolism of drugs; 5) laboratory tests (blood routine, urine routine, blood biochemical tests, etc.) have found clinically significant abnormalities; 6) The index of liver and kidney function examination exceeds the normal range and the researcher considers it clinically significant; 7) Electrocardiogram abnormality (with clinical significance) or abnormal vital signs (SBP 140 mmHg, DBP 90 mmHg; heart rate 100 bpm); 8) positive HIV testers and positive syphilis testers; 9) Hepatitis B surface antigen test positive or hepatitis C positive test; 10) Alcoholics or regular alcoholic drinkers within 6 months before the test, ie drinking more than 14 alcohol per week (1 unit = 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine); 11) Smokers (any tobacco products are not allowed during the trial); 12) Drug abusers who have used soft drugs (eg cannabis) for the first 3 months of the trial or hard drugs (eg cocaine, phencyclidine, etc.) during the first year and during the trial; 13) Any food allergies or foods that have special requirements and cannot follow a unified diet; 14) Those who drink excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups) per day; 15) Any drug that inhibits or induces drug metabolism in the liver during the first 3 months or during the trial (eg inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibition Agents - SSRI antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 16) Those who took any drug within 14 days before the test; 17) Those who took any clinical trial drugs or participated in any clinical clinical trial within 3 months before the trial; 18) Blood donation or as a subject was sampled 3 months before the test; 19) Pregnancy; 20) The subject may not be able to complete this study for other reasons or the investigator believes it should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetic parameter;Blood concentration; | — |
Countries
China
Contacts
Public ContactJinliang Yao
Yantai YenePharma Co., Ltd
Outcome results
None listed