Acute ischemic stroke
Conditions
Interventions
Single first dose group:Y-6 sublingual film /y-6 sublingual film blank film
Single second dose group:Y-6 sublingual film /y-6 sublingual film blank film
Single third dose group:Y-6 sublingual film /y-6 sublingual film blank film
Multiple first dose group:Y-6 sublingual film /y-6 sublingual film blank film
Multiple second dose group:Y-6 sublingual film /y-6 sublingual film blank film
Sponsors
Liuzhou workers hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all the following criteria to be selected: 1) Healthy adult male and female subjects, aged between 18-45 years (including both ends); 2) Male weight = 50kg, female weight = 45kg, body mass index (BMI) between 19-26kg / m2 Between (including values at both ends); 3) Subjects who can understand and sign informed consent before any test related procedures
Exclusion criteria
Exclusion criteria: Subjects who meet one or more of the following criteria will be excluded: 1) Clarify the previous p-cilostazol, d-camphor or any other excipients (hydroxypropyl beta cyclodextrin Covidone, mannitol, microcrystalline cellulose, pregelatinized starch, cross-linked povidone, cross-linked sodium carboxymethyl cellulose, citric acid, sodium bicarbonate, stevioside, silicon dioxide, magnesium stearate) allergy; 2) Those who have suffered or are currently suffering from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, convulsion and metabolic abnormalities, and are judged by the researcher to be clinically significant; 3) Those who have a history of repeated oral ulcer or have oral ulcer, serious oral damage and no recovery within 14 days before screening, or the researchers check and confirm the abnormality of oral mucosa; 4) Those whose vital signs, electrocardiogram, laboratory examination (blood routine, urine routine, coagulation function, blood biochemical examination, etc.) and other screening examinations are abnormal and judged by the researcher to be of clinical significance; 5) Positive for human immunodeficiency virus antibody, Treponema pallidum specific antibody, hepatitis B surface antigen or hepatitis C antibody; 6) Alcoholics or regular drinkers within 6 months before screening, i.e. drinkers who drink more than 14 units of alcohol per week (1 unit = 360 ml beer or 45 ml spirits with 40% alcohol or 150 ml wine), or whose alcohol breath test results are greater than 0.0 mg/100 ml, or who cannot abstain from alcohol during the test; 7) Those who smoke more than 3 cigarettes per day on average within 3 months before screening, or who cannot give up smoking during the whole test period, or who are positive for nicotine screening; 8) Have a history of drug abuse, drug dependence or drug abuse screening positive; 9) Any person who is allergic to food or drugs or has special requirements for diet and cannot follow the unified diet; 10) Drinking too much tea, coffee and / or caffeinated beverages (more than 8 cups, 1 cup =250ml) or have taken special diet (including pitaya, mango, grapefruit, etc.); 11) Any drugs that inhibit or induce the metabolism of drugs in the liver (such as inducement) have been used within 2 months before screening Guiding agents barbiturates, carbamazepine, phenytoin, glucocorticoids, Omeprazole; Inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 12) Those who have taken any prescription or over-the-counter drugs, traditional Chinese medicine or Chinese herbal medicine, health products within 14 days before screening, or have received vaccination within 14 days before screening; Or plan to vaccinate during the trial; 13) Those who participated in any other drug clinical trials as subjects within 3 months before screening; 14) Those who donated blood or lost more than 200 ml of blood within 3 months before screening; 15) Had unprotected sex (female) within 14 days before screening or after screening until check-in, or was pregnant Pregnant or lactating women; 16) Male subjects (or their partners) or female subjects during the whole trial period and 3 after the end of the study There is a birth plan within months or the subjects are unwilling to take one or more non drugs during the trial Contr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-inf;Tmax;t1/2;?z;AUC_%Extrap;Vz/F;CL/F;MRT0-t;MRT0-8;Cav, ss;Cmax, ss;Cmin, ss;AUCt;AUC0-t, ss;AUC0-inf, ss;DF;Tmax, ss;t1/2, ss;CLss/F;Vss/F;?z;AUC_%Extrap;Ra(AUC);Ra(Cmax); | — |
Countries
China
Contacts
Public ContactYazhou Wang
Liuzhou Workers' Hospital
Outcome results
None listed