Basic Science
Conditions
Interventions
preprandial and postprandial:ASC16 tablet
Sponsors
Hu'nan Provincial Maternal and Child Health Care Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-45 years (including boundary value), both male and female; 2. The body weight of male subjects was more than or equal to 50.0 kg, and that of female subjects was more than or equal to 45.0 kg. The body mass index (BMI) was between 19-26 kg / m2 (including boundary value); 3. Subjects who voluntarily signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. (Consultation) patients who have suffered or are suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities or any other diseases that can interfere with the test results (such as known severe bleeding tendency, etc.); 2. (Consultation) patients with a history of allergy to drugs, food or other substances, or those allergic to any component of the product; 3. (Consultation) patients who had undergone surgery within 28 days before the trial, or planned to undergo surgery during the trial; 4. (Consultation) patients who have undergone gastrointestinal surgery, vagotomy, bowel resection or any surgery that may interfere with gastrointestinal peristalsis, pH or absorption. 5. (Consultation) patients who have used any medicine or health care products (including Chinese herbal medicine) within 14 days before the trial; 6. (Consultation) patients who used any clinical trial drug or were enrolled in any clinical trial within 3 months before the trial; 7. (Consultation) patients who donated blood or lost more than 200 ml of blood within 3 months before the trial; 8. (Consultation) subjects who had used oral contraceptives within 30 days before the trial, or who had used long-acting estrogen or progesterone injections or implants within 6 months before the trial. 9. (Consultation) those who had unprotected sex (female) within 14 days before the trial, or were unable to take one or more non drug contraceptives during the trial, or pregnant or lactating women; 10. (Consultation) subjects who have special dietary requirements can not follow the same diet; 11. (Consultation) subjects who drank too much tea, coffee or caffeinated beverage (more than 8 cups, 1 cup = 250 ml) every day within 3 months before the trial; 12. (Consultation) subjects who took the first time before taking the research drugs had consumed or planned to consume any food or drink containing caffeine (such as coffee, strong tea, chocolate, etc.) or foods rich in xanthine (such as sardine, animal liver, etc.) or beverages; and 13. (Consultation) smokers or subjects who smoked more than 5 cigarettes per day within 3 months before the experiment; 14. (Consultation) alcoholics or subjects who frequently drank alcohol within 6 months before the trial, i.e. drinking more than 14 units of alcohol per week (1 unit = 360 ml of beer or 45 ml of 40% alcohol or 150 ml of wine); 15. (Consultation) drug abusers or subjects who used soft drugs (such as marijuana) within 3 months before the trial or used hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial; 16. (Consultation) subjects with irregular defecation within 7 days before the trial; 17. Subjects with abnormal vital signs and clinical significance [reference range: 90 mmHg <= systolic blood pressure < 140 mmHg, 60 mmHg <= diastolic blood pressure < 90 mmHg, 60 beats / min <= pulse (rest) <= 100 beats / min; subject to the judgment of the research doctor], or subjects with abnormal physical examination, ECG, laboratory examination and other research doctors with clinical significance; 18. Subjects who failed in alcohol test or positive in drug abuse screening; 19. Subjects who may not be able to complete this trial due to other reasons or who the researcher thinks should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameter; | — |
Countries
China
Contacts
Public ContactLulu Chen
Changsha Duxact Biotechnology Co.,Ltd
Outcome results
None listed