MDD
Conditions
Interventions
15mg BID:Take amoxitine hydrochloride enteric-coated tablets/ blanktablets
30mg BID:Take amoxitine hydrochloride enteric-coated tablets/ blanktablets
45mg BID:Take amoxitine hydrochloride enteric-coated tablets/ blanktablets
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 18-45 years (including upper and lower limits), half male and female; 2) Weight = 45kg (female) or 50kg (male), 18kg/m2 = BMI (body mass index, weight / height 2) = 26kg / m2; 3) It is proved to be a healthy subject by various tests such as vital signs, physical examination, and laboratory examination; 4) Ability to voluntarily sign informed consent and voluntarily cooperate with the completion of the trial according to the plan.
Exclusion criteria
Exclusion criteria: 1) Those with allergies (allergic to 2 or more drugs, food or pollen); 2) those suffering from mental illness, liver and kidney function disease, gastrointestinal disease, nervous system disease or other related systemic diseases affecting the test; 3) A comprehensive examination of medical history, physical examination, ECG examination, chest X-ray examination, and viral markers to determine the clinically significant abnormalities; 4) during the screening period, the static sitting systolic blood pressure >140mmHg or diastolic blood pressure >90 mmHg; 5) Orthostatic hypotension (the systolic blood pressure drops 20mmHg or the diastolic blood pressure drops 10mmHg when standing in a supine position); 6) QTc interval = 450ms (male) or 470ms (female), or a history of prolonged QTc interval; 7) Smokers or alcoholics (14 units of alcohol per week for 4 weeks before screening: 1 unit = beer 285mL, or spirits 25mL, or wine 150mL; daily smoking = 5) or nearly 1 year Other substances or drug abusers; 8) The amount of blood donation or blood loss exceeds 400mL within 8 weeks before screening; 9) Those who have participated in other clinical trials within the first 3 months of screening; 10) Those who are used to excessive caffeine-containing beverages or foods within 4 weeks before screening, such as coffee, tea, chocolate, cola, and red bull (the daily caffeine intake does not exceed 6 units). 1 caffeine unit = 1 cup of coffee (177.4mL) = 2 listening to cola (354.9mL) = 1 cup of tea (354.9mL) = 1/2 cup energy drink = 85g chocolate; 11) Drugs or foods that use the activity of changing liver enzymes (CYP2C19 and CYP3A4) within 4 weeks before screening, such as dexamethasone, ketoconazole, rifampicin, omeprazole, grapefruit, etc.; 12) Prescription, over-the-counter (except occasional use of acetaminophen and nasal spray), herbs, vitamins or minerals, and drugs taken before screening have not completed 5 half-life metabolism, 2 drugs The middle half is the longer one; 13) Anyone who has used any psychotropic or psychoactive substance within 2 months prior to screening; 14) Female subjects are pregnant during pregnancy or during pregnancy or during pregnancy; 15) Subjects and their partners are reluctant to take any contraceptive measures from 2 weeks before dosing to 6 months after the end of the trial; 16) There are recent donor programs; 17) Those who have participated in this test; 18) The investigator believes that there are any subjects who are not eligible to participate in this test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine;Blood chemistry;Urine routine;Coagulation 5 items;Physical examination;vital signs;Electrocardiogram;Viral marker;ß2-microglobulin;Creatine kinase isoenzyme; | — |
Countries
China
Contacts
Public ContactPeng Yueying
CSPC
Outcome results
None listed