Parkinson's disease
Conditions
Interventions
T-R-T-R fast group:Under fasting conditions, subjects were orally administered the test formulation (0.2g/1 tablet) in Cycle 1, followed by the reference formulation (0.2g/1 tablet) in Cycle 2, the te
R-T-R-T fast group:Under fasting conditions, subjects were orally administered the reference formulation (0.2g/1 tablet) in Cycle 1, followed by the test formulation (0.2g/1 tablet) in Cycle 2, the re
T-R-T-R fed group:Under standardized high-fat meal conditions,subjects were orally administered the test formulation (0.2g/1 tablet) in Cycle 1, followed by the reference formulation (0.2g/1 tablet) i
R-T-R-T fed group:Under standardized high-fat meal conditions,subjects were orally administered the reference formulation (0.2g/1 tablet) in Cycle 1, followed by the test formulation (0.2g/1 tablet) i
Sponsors
The First Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The research participants fully understand the purpose, nature, methods of the trial and the possible adverse reactions, voluntarily sign the informed consent form, can communicate well with the researcher, and understand and abide by all the requirements of this study; 2. Participants in the healthy voluntary research who are 18 years old or above (including 18 years old) (both men and women are acceptable); 3. Male weight >=50.0kg, female weight >=45.0kg; The body mass index (BMI) is within the range of 19.0 to 26.0kg/m ² (including the critical value). 4. Male research participants had no plans to have children from the date of signing the informed consent form (within one month before the screening of female research participants) to three months after the end of the trial, and had no plans to donate sperm or eggs, and voluntarily took effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Have suffered from or are currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, or any other diseases that can interfere with the test results (e.g. : Those with hypertension, hypotension, malignant nerve block syndrome, non-traumatic rhabdomyolysis, pheochromocytoma, heart disease, and liver or kidney dysfunction; 2. People with allergic constitutions, those with a history of allergies to two or more foods or drugs, or those known to be allergic to Entacapone tablets and their analogues or any of their excipients (microcrystalline cellulose, mannitol, sodium cross-linked carboxymethyl cellulose, hydrogenated vegetable oil, magnesium stearate, hydroxypropyl methylcellulose, polysorbitate, glycerin, sucrose, red iron oxide, yellow iron oxide, titanium dioxide, etc.); 3. Individuals with fructose intolerance, glucose-galactose absorption disorders (who have experienced milk-induced diarrhea before), or sucrase - isomaltase deficiency, or those who have had significantly abnormal or special diets (such as dieting, low-sodium diet) within 30 days prior to screening, or have special dietary requirements and cannot accept a uniform diet; 4. Those who cannot tolerate venipuncture, have a history of fainting at the sight of needles and blood, or have difficulty in venous blood collection; 5. Those with a history of difficulty in swallowing or any gastrointestinal diseases that affect the absorption and metabolism of drugs; 6. Those who have a history of drug abuse or have used drugs (inquired) within the six months prior to screening, or who have tested positive in drug screening; 7. Female research participants who were pregnant or lactating before screening, had unprotected sexual behavior within one month before screening, used oral contraceptives within one month before screening, and used long-acting estrogen or progesterone injections or implants within six months before screening; 8. Those who have a history of alcohol abuse within 6 months prior to screening, or those who cannot stop drinking alcohol during the trial period. Alcohol abuse is defined as: men consuming more than 14 units of alcoholic beverages per week or women consuming more than 7 units of alcoholic beverages per week (1 unit =360mL of beer or 45mL of 40% alcohol or 150 ml of wine). 9. Those who have undergone surgical operations within the three months prior to screening or are planning to undergo surgery during the trial period, as well as those who have undergone surgeries that may affect drug absorption, distribution, metabolism, or excretion; 10. Those who have donated blood or lost a large amount of blood (>=200mL) within 3 months prior to screening, received blood transfusion or used blood products; 11. Those who smoked more than 5 cigarettes per day within the 3 months prior to screening or were unable to stop using any tobacco products during the trial period; 12. Those who consumed excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 mL) every day within the three months prior to screening; 13. Those who have received vaccination within one month prior to screening, or those who plan to receive vaccination during the study period; 14. Those who have taken any drugs that may have drug interactions with this product within one month prior to the screening (
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Time to peak concentration;Elimination rate constant;Terminal elimination half-life;Percentage of residual area; | — |
Primary
| Measure | Time frame |
|---|---|
| Peak concentration;AUC0-t, Area under the concentration-time curve from zero to the last measurable concentration;AUC0-8, Area under the concentration-time curve from zero to infinity; | — |
Countries
China
Contacts
Public ContactJianxin Wang
The First Hospital of Hebei Medical University
Outcome results
None listed