Parkinson’s disease
Conditions
Interventions
fasting administration group-TR:phase I: Pramipexole Extended-Release Tablets
fasting administration group-RT:phase I: Reference preparation: pahse II: Test preparation
high-fat postprandial administration group-TR:phase I: Pramipexole Extended-Release Tablets
high-fat postprandial administration group-RT:phase I: Pramipexole Extended-Release Tablets
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The body mass index (BMI) (kg / m2 of height) is 19-24; 2. The subjects in the comprehensive physical examination were normal in blood and urine routine examination, liver and kidney function examination and electrocardiogram examination, but HBsAg was negative; 3. After knowing the content of the experiment, the volunteers were willing to participate in the experiment and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who have history of drug and food allergy, allergic disease or allergic constitution; 2. Patients with a history of chronic or organic diseases or heart, liver, kidney and blood system diseases; 3. Subjects who have participated in other drug trials within 2 months before the trial; 4. Subjects who participated in blood donation within 3 months before the experiment; 5. Subjects who have used any drugs (including traditional Chinese Medicine) within 2 weeks; 6. People who often use drugs, drink or smoke; 7. Subjects with poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma drug concentration;Pharmacokinetic parameters(Cmax, AUC0-t, AUC0-8, Tmax, t1/2, ?z, AUC_%Extrap, etc.);Safety evaluation indicators (adverse events, serious adverse events, clinical laboratory results, etc.); | — |
Countries
China
Contacts
Public ContactZhu Luo
West China Hospital of Sichuan University
Outcome results
None listed