Parkinson's Disease
Conditions
Interventions
3:Phase 1 take test preparation after meal
Phase 2 take control product after meal
4:Phase 1 take control product after meal
Phase 2 take test preparation after meal.
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 year-old male and female subjects (including 18 and 65 years old); 2. Weight >=50 kg, BMI >=19 and <=26kg/m2, body mass index (BMI) = body weight (kg)/height 2 (m2); 3. Before the test history, physical examination, ECG, chest X-ray, laboratory tests related to the project and, examinations were normal or mildly abnormal no clinical significance, clinical research physician judgment that the qualifier; 4. No smoking, alcohol and other bad habits, no history of drug abuse; 5. No known drug allergies and biological agents; 6. Non-lactating female subjects, a negative pregnancy test; 7. Volunteered to participate in this clinical trial, understanding research procedures and signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Vital signs, physical examination, electrocardiogram, chest X-ray and various abnormal laboratory test results and clinical significance; 2. Central nervous system, cardiovascular system, liver and kidney dysfunction, gastrointestinal system (especially the history of pancreatitis), respiratory system, metabolic disorders and skeletal system history (in particular: hypotension, orthostatic hypotension, Parkinson's disease, epilepsy, headache or migraine, etc.), or any other that may affect the results of those diseases and physiological conditions; 3. In the past five years with a history of drug abuse or three months before the trial who used drugs; 4. Have a history of atopy (such as allergic dermatitis, asthma, etc.), or drug allergies and biological agents, or drug ingredients are known to present a history of allergies; 5. Used any drugs that may affect the excretion of this long study, or who are using any drugs; 6. 2 weeks before the test had taken special diets (including dragon fruit, mango, grapefruit, and / or xanthine diet)) or strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors are. 48 hours prior to administration orally used chocolate, caffeinated coffee or tea, or caffeinated and any other food or drink; 7. Special dietary requirements and can not comply with the diet and the corresponding provisions provided; 8. Before the test within 3 months frequent drinkers, ie drinking more than 14 units of alcohol per week (1 unit = 360 mL or 45 mL of beer alcohol content of 40 per cent of spirits or wine 150 mL); 9. Three months before the trial daily cigarette consumption by more than 5; 10. Nearly a year as the subjects participated in three or more than three times the drug's clinical trials; to participate in this trial within the first 3 months as the subjects participating in clinical trials of any drug, or within 3 months who had blood greater than 400mL; 11. Known active hepatitis B, HIV, HCV virus and Treponema pallidum infection; 12. Subjects did not take effective contraceptive measures or have birth plan within six months, or female subjects positive pregnancy test; 13. Researchers believe that poor compliance, or any subject should not participate in this test factors; 14. I researchers and research institutions related to personnel and their families; 15. Other reasons may be because the subject of this study can not be completed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration of Pramipexole; | — |
Countries
China
Contacts
Public ContactYanhua Ding
The First Hospital of Jilin University
Outcome results
None listed