parkinsonism
Conditions
Interventions
Fasting Group A:T-R
Fasting Group B:R-T
Fed Group A:T-R
Fed Group B: R-T
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Subjects are fully aware of the objectives, nature, method, and possible adverse effects of the trial, volunteer as a subject, and sign an informed consent form prior to the start of any research procedure; 2) Healthy subjects aged 18 years and older (including 18 years old), both male and female; 3) Male weight = 50.0kg, female weight = 45.0kg; body mass index (BMI) is within the rangeof 19.0 ~ 28.0kg / m2 (including the threshold); 4) Subjects (including male subjects) have no birth plans in the next 6 months and voluntarily adopt effective contraceptive measures (please refer to Appendix 3), and there is no donor or donation plan; 5) Subjects are able to communicate well with the investigator, understand and comply with the requirements of this trial.
Exclusion criteria
Exclusion criteria: 1) Those who are allergic torasagilineor any component of its preparations; 2) The illness that may significantly affect the absorption, distribution, metabolism and excretion of the drug, the history of surgery, the medical history and any other circumstances related to the test drug; 3) Those who have undergone surgery within 3 months prior to screening, or who plan to undergo surgery during the study period; 4) Diseases with abnormal clinical manifestations and need to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, endocrine, immune system, kidney, liver (including active Hepatitis B), gastrointestinal tract, breathing system, metabolic and skeletal, mental, neurological and other systemic diseases; 5) Those who cannot tolerate venipuncture, who have a history of fainting andbloodphobia; 6)Donate blood (including blood components) or a large amount of blood loss (=200mL), receive blood transfusion or use blood productswithin 3 months before screening; 7) Vital signs (including body temperature [forehead temperature], pulse, blood pressure, breathing), physical examination, clinical laboratory tests (blood routine, urine routine, blood biochemistry, virological examination, blood pregnancy examination [female]), 12 leads ECG: any resultis abnormal and clinical significance is determined by the investigator, or who have not completed the examination; 8) Those who with abnormal results of alcohol breath test, or with positive drug abuse screening (marijuana, benzodiazepines, ketamine, morphine, cocaine, methamphetamine), orwith positive nicotine screening; 9) Those who have used amines within 2 weeks before dosing, and who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and vitamins; 10) The number of daily smoking is greater than 5 within 3 months before screening, or the use of any tobacco products cannot be stopped during the trial; 11) Drinking more than 14 units per week for 3 months prior to the screening (1 unit of alcohol˜ 360 mL of beer, or 45 mL of spiritswith 40% alcohol, or 150 mL of wine), oralcoholcannot be stoppedduring the study period; 12) Drink excessive tea, coffee and/or caffeinated beverages (8 cups or more, 1 cup = 250mL) daily for 3 months prior to the screening; 13) Female subjects are in the lactation period during the screening period or during the trial, or the pregnancy test results are positive; 14) Participated in other drug clinical trials within 3 months prior to dosing; 15) Those who have special dietary requirements and cannot accept a unified diet. Study requirements: fasting barbecue food, banned grape juice/apple juice/grapefruit juice/caffeine or alcohol (including chocolate, tea, coffee, cola, etc.), fasted with tyramine-rich foods (such as cheese); 16) The investigator determines other circumstances that are not suitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure;Pulse;Temperature;ECG;Blood Routine Examination;Routine Urine Examination;Blood Biochemical; | — |
Countries
China
Contacts
Public ContactXinghe Wang
Beijing Shijitan Hospital Capital Medical University
Outcome results
None listed