Ulcerative colitis
Conditions
Interventions
Fasting group:phase I: T-R
phase II: R-T
post-prandial group:phase I: T-R
Sponsors
Nanjing Nanhua orthopedic Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Chinese healthy male or female subjects aged >= 18 years; 2. Body weight: male >= 50 kg, female >= 45 kg, body mass index (BMI) = body weight (kg) / height (M 2), body mass index in the range of 19.0-26.0 (including boundary value); 3. Subjects with good health, no history of heart, liver, kidney, digestive tract, endocrine, blood system, respiratory system, nervous system, mental disorders and metabolic abnormalities, normal or abnormal physical examination, ECG, vital signs, laboratory items and test related examinations and tests, which are judged as qualified by clinicians; 4. The subjects had no family planning and were willing to take effective contraceptive measures within 3 months from the signing of informed consent to the last administration; 5. Subjects who understand and follow the research process, participate voluntarily, and are willing to sign the informed consent form. Those who do not meet one of the above conditions shall not be selected as subjects.
Exclusion criteria
Exclusion criteria: Any of the following circumstances shall be excluded. 1. Patients with nervous / mental system, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, skeletal muscle system or any other diseases or physiological conditions that may affect the results of the study; 2. Patients with a history of drug or food allergy or specific allergic diseases (such as asthma, urticaria, eczema dermatitis, etc.); 3. Patients with rheumatoid arthritis; 4. Patients with glucose-6-phosphate dehydrogenase deficiency (commonly known as broad bean disease); 5. Patients with HIV antibody, HBsAg, HCV antibody or Treponema pallidum antibody are all positive; 6. Patients with drug abuse history or positive urine drug screening [methamphetamine (methamphetamine), dimethylene dioxoamphetamine (ecstasy), tetrahydrocannabinolic acid (cannabis), morphine, ketamine] within 12 months before screening; 7. The subjects who often drank alcohol within 6 months before screening, i.e. those who drank more than 14 units of alcohol per week on average (1 unit ˜ 200 ml of beer with 5% alcohol content or 25 ml of spirits with 40% alcohol content or 85 ml of wine with 12% alcohol content) or those who could not give up drinking alcohol 48 hours before administration until the end of the study or whose alcohol breath test was positive; 8. Subjects who smoked more than 5 cigarettes per day on average in the first 3 months or who could not give up smoking 48 hours before administration until the end of the study were screened; 9. The subjects who had donated blood in the first 3 months or had lost more than 400 ml of blood in 6 months were screened (except for female physiological bleeding); 10. Subjects who had participated in other clinical trials within 3 months before screening; 11. Subjects who have used any prescription drug, over-the-counter drug, traditional Chinese medicine or health care product for their own disease treatment and / or prevention within 4 weeks before screening; 12. There are special requirements for diet, and the provided diet and corresponding regulations cannot be observed. It is impossible to avoid the consumption of beverages (coffee, tea, cola, etc.) containing xanthine / caffeine or food (animal liver, chocolate), or the consumption of grapefruit, grapefruit, mango and other fruits or fruit juice that may affect metabolism 48 hours before administration until the end of the study; 13. Subjects with difficulty in venous blood collection or fainting from acupuncture; 14. Subjects of pregnant or lactating women; 15. Subjects who were not considered suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration in blood; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Countries
China
Contacts
Public ContactCheng Zhaohui
Nanjing Nanhua Orthopedic Hospital
Outcome results
None listed