Parkinson’s disease,PD
Conditions
Interventions
Fasting - Group 1(Group T-R-T-R):1 tablet of the subject formulation orally on an empty stomach in the first cycle, 1 tablet of the reference formulation orally on an empty stomach in the second cycle
Fasting - Group 2(Group R-T-R-T):1 tablet of fasting oral reference preparation in the first cycle, 1 tablet of fasting oral test preparation in the second cycle, 1 tablet of fasting oral reference pr
Postprandial group - Group 1(Group T-R-T-R):In the first cycle, one tablet of oral test preparation was taken after eating a high-fat and high-heat meal, one tablet of oral reference preparation was t
Postprandial group - Group 2(Group R-T-R-T):In the first cycle, one tablet of oral reference preparation was taken after eating a high-fat and high-heat meal, one tablet of oral test preparation was t
Sponsors
Zhejiang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1)The subject fully understands the purpose, nature, method and possible adverse reactions, and voluntarily serves as a test and sign informed consent before any research procedure begins; (2) Healthy subjects aged 18 to 60 (including 18 and 60 years old), both male and female; (3) Male weight >=50.0 kg, female weight >=45.0 kg; body mass index (BMI) range 19.0~26.0 kg/m 2 (including critical value); (4) Vital signs examination, physical examination, laboratory examination (four items of blood routine, urine routine, blood biochemistry, infection, coagulation blood function, female blood pregnancy), 12-lead electrocardiogram, etc., and the results show normal or abnormal no clinical significance; (5) Subjects (including male subjects) have no fertility within 3 months after signing informed consent form until the last dose voluntarily take effective contraceptive measures (Appendix 2) without sperm and egg donation plans.
Exclusion criteria
Exclusion criteria: (1) Individuals with a history of specific allergies (asthma, urticaria, eczema, etc.), or hypersensitivity (e.g., to two or more drugs, foods, or pollens), or known allergy to components of this drug or analogues; (2) Those with a history of chronic or serious diseases of the cardiovascular, hepatic, renal, haematological and lymphatic, endocrine, immune, psychiatric, neurological, gastrointestinal, respiratory, metabolic, and skeletal systems (e.g., hepatic damage, impulse control disorders (ICDs), melanoma, etc.); (3) Those with a history of any gastrointestinal disorder that interferes with drug absorption; (4) Those with dysphagia; (5) Those who have undergone surgery within 3 months prior to screening, or plan to undergo surgery during the study period, and those who have undergone surgery that would affect drug absorption, distribution, metabolism, or excretion; (6) Those who have difficulty with venipuncture, those who cannot tolerate venipuncture, and those who have a history of needle and blood-sickness; (7) Those with a history of drug addiction or drug abuse; (8) Persons who screened positive for drug abuse (morphine, tetrahydrocannabinolic acid (THC), methamphetamine, methylenedioxymethamphetamine (MDMA), and ketamine) before or during the trial; (9) Participation in another clinical trial of a drug within 3 months prior to screening or coming to a clinical trial other than in person; (10) Those who have donated blood including component blood or large amount of blood loss (>= 400 mL, except blood loss during normal physiological period for women), received blood transfusion or used blood products within 3 months prior to screening; (11) who have used drugs that interact with resagiline within 28 days prior to screening (e.g., dextromethorphan or sympathomimetics (e.g., nasal or oral decongestants containing ephedrine or pseudoephedrine and cold and flu medications), other monoamine oxidase inhibitors (also natural medications such as St. John's wort), CYP1A2 inhibitors (e.g., ciprofloxacin), pethidine, fluoxetine, fluvoxamine, anti-depressants, entacapone, etc.) or any drug that inhibits or induces drug metabolism by hepatic enzymes; (12) Anyone who has used any prescription, over-the-counter, herbal and/or nutraceutical medications within 14 days prior to screening; (13) Persons who have been vaccinated within 28 days prior to screening or who plan to be vaccinated during the trial; (14) Persons who have smoked more than 5 cigarettes per day in the 3 months prior to screening, or who are unable to stop using any tobacco-based products during the trial period; (15) Drinking >14 units of alcohol per week (1 unit of alcohol ˜ 360 mL of beer or 45 mL of 40% alcohol by volume spirits or 150 mL of wine) in the 3 months prior to screening, or unable to abstain from alcohol during the trial; (16) Those who consumed excessive amounts of tea, coffee, and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day during the 3 months prior to screening; (17) Those who cannot commit not to consume dragon fruit, mango, grapefruit, lime, popcorn or food or drinks prepared from them, chocolate and any caffeinated (e.g., coffee, strong tea, cola, etc.) beverages from 3 days prior to admission to the Phase I study room to the period of admission for each cycle; (18) Persons with special dietary requirements or lactose intolerance (those who have experienced diarrhoea from drinking milk) who are unable to comply with the uniform di
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum blood drug concentration;From 0 to the final time point t, the concentration-area under the time curve, the plasma concentration can be determined;Blood drug concentration-area under time curve from 0 to infinite time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak time;Eliminate half-life;Elimination rate constan;Residual area percentage; | — |
Countries
China
Contacts
Public ContactWanggang Zhang/Chen Jun
Zhejiang Hospital
Outcome results
None listed