Parkinsonism
Conditions
Interventions
Postprandial group:The test preparation or reference preparation of benzoxol hydrochloride tablets should be taken cross-over after two cycles of meals
Fasting group:Two cycles of fasting cross administration of benxoxol hydrochloride tablet test preparation or reference preparation
Sponsors
Taizhou Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject understands the purpose and requirements of the trial, agrees to abide by the trial management regulations, and voluntarily signs the informed consent form; 2. Healthy subjects aged 18 years old (inclusive) or above, both male and female; 3. Body mass index (BMI) within [19.0~26.0], including the cut-off value [BMI=weight/height2(kg/m^2)], male weight >=50.0kg, female weight>=45.0kg; 4. The subject (or his partner) has no fertility plan (including sperm donation and egg donation) and voluntarily takes effective contraceptive measures from 2 weeks before signing the informed consent form to 3 months after the last dose of the investigational drug.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of major diseases of the nervous system, mental system, cardiovascular system, endocrine system, digestive system, urinary system, reproductive system, immune system, respiratory system (including but not limited to glaucoma, hypertrophy of the prostate, urinary retention, arteriosclerosis, tartaric dyskinesia, mental disorders) that may affect the evaluation of the study results; 2.Have any history of gastrointestinal disease (such as irritable bowel syndrome, bowel disease or inflammatory bowel disease), any history of biliary disease (such as acute or chronic cholecystitis, cholangitis, gallstones, cholestasis, etc.), or any surgical history of gastric or small intestinal resection, cholecystectomy, etc., that may affect drug absorption, Or have a history of atrophic gastritis, pancreatitis, esophageal reflux, gastrointestinal bleeding, peptic ulcer, obstruction, etc.; 3.The patient has a history of vomiting, diarrhea or any physiological condition that can interfere with the test results within 7 days before signing the informed consent; 4.Allergic constitution, clinical history of food, drug and other allergies, especially allergic to any component of the drug used in the test; 5.Had a major surgical procedure within 1 year prior to signing the informed consent, or planned to have surgery during the trial period; 6.Use of prescription drugs (including vaccines), non-prescription drugs, Chinese herbs or health products within 14 days before signing the informed consent; 7.Use of any drug that inhibits or induces liver drug metabolism enzymes (e.g., inducers - rifampicin, efavir, barbiturates, carbamazepine, phenytoin, glucocorticoids) within 28 days before signing the informed consent; Inhibitors: SSRI antidepressants, omeprazole, cimetidine, Diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, fluoroquinolones, antihistamines, itraconazole, fluconazole); 8.Any drugs that may interact with the drugs used in the study, such as central nervous system inhibitors, amantadine, anticholinergics, monoamine oxidase inhibitors, acid drugs, adsorbent antidiarrheal agents, cardiac glycosides, etc. that have been used within 28 days before signing the informed consent or during the study period shall not be given up; 9.Have participated in any drug or medical device clinical trial within 3 months before signing the informed consent; 10.Patients with total blood loss =400ml due to blood donation or other reasons within 3 months before signing the informed consent (except for female physiological blood loss), or who plan to donate blood components during the trial or within 3 months after the trial; 11.People who have taken a special diet (such as grapefruit or grapefruit products, pomelo, dragon fruit, etc.) in the 7 days prior to the administration of the experimental drug and cannot guarantee the abstinent of xanthine-rich, caffeinated or alcoholic beverages or foods (such as animal offal, coffee, strong tea, chocolate, cola, etc.) from 48 hours prior to the administration until the end of the trial; 12.Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250ml) per day within 3 months prior to signing the informed consent; 13.Patients who have a history of needle fainting or blood fainting, or who cannot tolerate venous puncture blood collection, or who have difficulty collecting blood; 14.People who have special requirements for diet and cannot comply w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of residual area;Peak concentration, AUC0-T, AUC0-8, time to peak concentration, elimination terminal half-life, elimination rate constant;Relative bioavailability;Total body clearance;Apparent volume of distribution; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs (blood pressure (sitting), body temperature (ear temperature) and pulse);Physical examination;Laboratory tests (blood routine, blood biochemistry, coagulation test, urine routine);12-lead ECG;Blood pregnancy test (only for women of childbearing age); | — |
Countries
China
Contacts
Public ContactXu Luwei
Taizhou Hospital of Traditional Chinese Medicine
Outcome results
None listed