None
Conditions
Interventions
Fasting group (RTRT):reference preparation- test preparation- reference preparation- test preparation
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male and female subjects, aged 18 years old or above (including 18 years old); 2. The weight of male subjects should not be less than 50.0 kg, the weight of female subjects should not be less than 45.0 kg, and the body mass index (BMI) should be within the range of 19.0~26.0kg/m2 [BMI = weight (kg)/height 2 (m2)] (including the cut-off value); 3. Sign the informed consent form before screening, and fully understand the content, process and possible adverse reactions of the trial; and be able to complete the study in accordance with the requirements of the test protocol.
Exclusion criteria
Exclusion criteria: 1. Clinically significant diseases that have occurred or are occurring within 12 months prior to screening, including but not limited to neurological/psychiatric, respiratory, cardiovascular and cerebrovascular systems, digestive tract systems (with a history of dysphagia or any gastrointestinal diseases that affect drug absorption), blood and lymphatic system, liver and kidney function, endocrine system, and immune system diseases; 2. Those who have occurred or are experiencing abnormal clinical manifestations that need to be excluded before screening, such as intracranial hemorrhage, gastrointestinal bleeding or perforation, coagulation disorders, etc., or history of hypotension; 3. Those who have undergone surgery within 3 months before screening or plan to undergo surgery during the study, and the surgery will affect the absorption, distribution, metabolism and excretion of drugs; 4. Female subjects who have a pregnancy plan and are unwilling to take effective contraceptive measures (see Appendix 1 of the protocol) since two weeks before screening or male subjects from the first dose to 6 months after the last dose of study drug, or those who have sperm donation in men and egg donation plans in women; 5. Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, infectious disease screening, coagulation routine, serum pregnancy examination (only for women of childbearing age)), 12-lead electrocardiogram examination judged by the investigator to be abnormal and clinically significant; 6. Those with a history of specific allergies (such as asthma, urticaria, eczema, etc.), or those with allergies (two or more drugs, food allergies), or those who are known to be allergic to nicorgoline tablets and any of its components, ergot alkaloids and their derivatives; 7. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health care products within 2 weeks before screening; 8. Those who have an average weekly alcohol consumption of more than 14 units (1 unit of alcohol ˜ 360mL of beer or 45mL of spirits with 40% alcohol content or 150mL of wine) in the 3 months prior to screening, or who do not agree or cannot stop consuming any alcoholic products during the trial period (from screening to discharge from the hospital in the last cycle); 9. Those who smoke more than 5 cigarettes per day on average in the 3 months before screening, or who do not agree or cannot stop using any tobacco products during the trial period (from screening to discharge from the last cycle); 10. Those who have donated blood or lost a large amount of blood (>400mL) within 3 months before screening, or who plan to donate blood during the trial or within one month after the end of the trial; 11. Those who have used drugs or have a history of drug abuse within 12 months before screening; 12.Use of any drug that inhibits/induces hepatic metabolism of drugs within 30 days prior to screening (such as: inducers--barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors - SSRIs antidepressants, cimetidine, diltiazem, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); or any drug that alters the gastrointestinal environment (e.g., proton pump inhibitors tetoprazole, omeprazole, lansoprazole, esoprazole, etc.; H2 antagonists ranitidine, cimetidine, famotidine, etc.; antacids sodium bicarbonate, magnesium oxide, alumi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical examination;vital signs;12 lead electrocardiogram;laboratory examination;adverse events; | — |
Countries
CHINA
Contacts
Public Contactchen guilin
Shulan (Hangzhou) Hospital
Outcome results
None listed