Improvement of cerebral circulation after ischemic cerebrovascular disease, and can also be used in the treatment of peripheral vascular disease, such as chronic occlusive vasculitis with intermittent claudication.
Conditions
Interventions
Fasting experimental group (T-R-T-R):In the first week, 21 subjects took the test preparation agent (T) 400mg orally with 240mL water after fasting. After the cleaning period for 7 days, the reference
High-fat postprandial group(T-R):In the first cycle, the subjects took the test preparation (T) orally with 240mL water 30 min after having a high-fat postprandial. The second cycle of administration
Fasting experimental group (R-T-R-T):In the first week, 21 subjects took the reference preparation (R) 400mg orally with 240mL water after fasting. After the 7-day cleaning period, the tested preparat
High-fat postprandial group (R-T):In the first cycle, the subjects took the reference preparation (R) orally with 240mL water 30 min after having a high-fat postprandial. The second cycle of administr
Sponsors
Affiliated Hospital of Hebei University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Subjects are fully aware of the purpose, nature, methods, and possible adverse effects of the trial, volunteer as subjects, and sign an informed consent form prior to the start of any study procedures; 2) Healthy male and female subjects aged 18 to 45 years (including 18 and 45 years) with an appropriate gender ratio; 3) Men weighing >=50.0 kg and women weighing >=45.0 kg with a body mass index (BMI) in the range of 19.0 to 26.0 kg/m2 (including threshold values); 4) Those whose vital signs examination, physical examination, and screening clinical laboratory tests show normal results or whose abnormalities are judged by the investigator to be of no clinical significance; 5) Subjects who are able to communicate well with the investigator and who understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1) Persons with a history of allergy to hexacosanolide extended-release tablets or any of the drug components; or persons with allergies: e.g., persons with allergies to two or more drugs or foods, or persons with a history of allergy to the same type of drug; 2) Chronic diseases or serious diseases of the cardiovascular system, digestive system, genitourinary system, respiratory system, blood system, endocrine system, immune system, psycho-neurological system, skeletal system, etc. (e.g., known serious bleeding tendency, coronary heart disease, etc.); with gastro-intestinal dysfunction, peptic ulcer, gastro-intestinal surgery, etc. or surgical history of diseases affecting the absorption, distribution, metabolism and excretion of drugs; 3) Those who have undergone surgery within 3 months prior to screening or who plan to undergo surgery during the study period; 4) Those who have used any medicines or healthcare products within 14 days prior to the screening, and those who have been vaccinated; 5) Any drug that inhibits or induces hepatic metabolism of a drug (e.g., inducers - barbiturates, carbamazepine, phenytoin sodium, rifampicin, etc., inhibitors - SSRI antidepressants, cimetidine, cyclosporine, macrolides, verapamil, quinolones, pyrrolobutin antifungals, HIV protease inhibitors, etc.) within the last 30 days prior to Screening; 6) History of substance abuse within 6 months prior to screening; 7) Drug use within 3 months prior to screening; 8) Drinking more than 14 units of alcohol per week (1 unit = 17.7mL of ethanol, i.e., 1 unit = 357mL of 5% alcohol beer or 43mL of 40% alcohol white wine or 147mL of 12% alcohol wine) in the 3 months prior to the screening period, or those who were unable to abstain from alcohol during the trial; 9) Those who smoked >5 cigarettes per day in the 3 months prior to screening or who were unable to stop using any tobacco-based products during the trial; 10) Consumption of excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250mL) per day during the 3 months prior to screening; 11) Consumption of xanthine-rich beverages (coffee, tea) or foods (chocolate, sardines, animal liver, etc.) within 1 week prior to screening, or consumption of grapefruit, pomelo, mango, fruits or juices that may affect metabolism; 12) Lactose or galactose intolerance; 13) Persons with special dietary requirements who are unable to comply with the diet provided and the corresponding regulations; 14) who have donated or lost >=400mL of blood within 3 months prior to screening, or who intend to donate blood and receive blood products (including blood components) during the trial or within 3 months after the completion of the trial; 15) Participation in a clinical trial of another drug within 3 months prior to screening; 16) Planned childbearing or unwillingness to use effective contraception or planned sperm or egg donation from 2 weeks prior to the screening date until 6 months after the last dose of study drug; 17) Individuals who cannot tolerate venipuncture and have a history of needle and blood sickness; 18) Those who have difficulty swallowing; 19) Women who are pregnant or breastfeeding; 20) Subjects who, in the judgment of the Investigator, are not suitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax ; | — |
Countries
China
Contacts
Public ContactYongchen Zhao
Affiliated Hospital of Hebei University
Outcome results
None listed