Healthy subjects
Conditions
Interventions
Sponsors
Institute of Clinical Pharmacology, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Aged >18 years old men and women; (2) The body weight of male subjects was more than 50.0 kg, that of female subjects was more than 45.0 kg, and the body mass index (BMI) ranged from 19.00 kg/m2 to 26.00 kg/m2 (including the boundary value); (3) Subjects voluntarily signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Any serious clinical illness, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormality, or any other illness that can interfere with the results of the test; 2. those who have allergic history of drugs, food or other substances; 3. Those who underwent surgery within 4 weeks before the trial or who planned to undergo surgery during the study period; 4. Those who have used any medicines and health products (including Chinese herbal medicine) within 14 days before the trial; 5. Within 30 days before the trial, any drugs that inhibit or induce liver metabolism (e.g. inducers - barbiturates, carbamazepine, phenytoin sodium, rifampicin; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, vera) were used. Pamide, fluoroquinolones, antihistamines, etc. 6. Those who took any clinical trial drug or were enrolled in any clinical trial within three months before the trial; 7. Blood donation or blood loss exceeding 400 mL within 3 months before the trial; 8. No one or more non-drug contraceptives or pregnant and lactating women can be used during the trial; 9. Those who have special dietary requirements and can not follow the unified diet; 10. Irregular bowel movements in the past week; 11. Patients with gastrointestinal disorders; 12. Those who drank excessive tea, coffee and/or caffeine-containing beverages (more than 8 cups, 1 cup = 250 mL) every day for three months before the trial; 13. Intake or plan to ingest grapefruit or citrus fruit related to grapefruit (such as lime, grapefruit), carambola, papaya, pomegranate or more fruit products three days before taking the first study drug; 14. Smokers or those who smoked more than 5 cigarettes a day three months before the trial; 15. Alcoholics or regular drinkers within six months prior to the trial, i.e., those who drank more than 14 units of alcohol per week (1 unit = 360 mL beer or 40% spirits or 150 mL wine with 45 mL alcohol); 16. Subjects who abuse drugs or have used soft drugs (e.g. cannabis) or hard drugs (e.g. cocaine, phenylcyclohexylpiperidine) three months before the test or one year before the test; 17. Clinical significance of abnormal vital signs (normal range: 90 mmHg < systolic blood pressure < 140 mmHg, 60 mmHg < diastolic blood pressure < 90 mmHg, 60 times / score < pulse (rest) < 100 times / score; based on the judgement of clinicians) or physical examination, electrocardiogram, drug abuse screening, laboratory examination, etc. clinicians judge that abnormalities are imminent. Those with abnormal bed or alcohol breathing test have clinical significance. 18. Subjects may not be able to complete the experiment for other reasons or those whom the researchers believe should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Genotype;PK parameter; | — |
Countries
China
Contacts
Public ContactDongsheng Ouyang
Changsha Duxact Biotech Co., Ltd.
Outcome results
None listed