Acute Ischemic Stroke (AIS)
Conditions
Interventions
Part 1:A single-center, randomized, open-label, three-preparation, three-period, crossover design was adopted. According to the randomization results, subjects received, in three separate periods, an
Part 2:Based on the PK data from the first part of the trial, a PK model will be established, and appropriate extrapolation and prediction will be conducted to determine the appropriate clinical doses
Part 3:Based on model predictions, two lyophilized powder doses (T4 and T5) will be selected to conduct the multiple-dose study. According to the results of the multiple-dose administration, parameter
both doses will be adjusted based on the trial results of Part 1 and Part 2). Each dose group will enroll 12 healthy subjects, and the low-dose group will be initiated first.
The 113 oral lyophilized
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Male or female subjects aged 18 to 55 years old (inclusive of the boundary values); 2.For male subjects, body weight >= 50.0 kg; for female subjects, body weight >= 45.0 kg; and body mass index (BMI) ranging from 19 ~26 kg/m^2 (inclusive of the critical values); 3.Subjects voluntarily sign the informed consent form, and have a full understanding of the trial content, process, and potential adverse reactions; 4.Subjects are able to communicate well with researchers, and understand and comply with all requirements of this study.
Exclusion criteria
Exclusion criteria: 1.Subjects with clinically significant abnormalities identified through medical history inquiry, physical examination, vital sign measurements (blood pressure, body temperature, pulse rate), as well as tests including routine blood tests, blood biochemistry, routine urine tests, 12-lead electrocardiogram (ECG), coagulation function, hepatitis B surface antigen (HBs-Ag), human immunodeficiency virus (HIV) antigen-antibody, hepatitis C virus (HCV) antibody, and Treponema pallidum antibody; 2.(Screening period/admission interview) Subjects with a history of diseases associated with a severe bleeding tendency; 3.(Screening period/admission interview) Subjects with a history of severe diseases or chronic diseases involving the heart, liver, kidneys, endocrine system, digestive system, hematological system, respiratory system, immune system, or nervous/psychiatric system, or current diseases affecting any of these systems; 4.(Screening period/admission interview) Subjects who have used any medications (including prescription drugs, over-the-counter drugs, vitamin supplements, or Chinese herbal medicines) or health supplements within two weeks prior to admission; 5.(Screening period/admission interview) Subjects who have received a vaccine within two weeks prior to admission or plan to receive a vaccine during the trial period; 6.(Screening period interview) Subjects with a known allergy to celery, butylphthalide, or their excipients, or allergies to other drugs or foods; 7.(Screening period/admission interview) Subjects with a history of drug abuse or who have used illegal drugs within one year; 8.(Screening period/admission interview) Subjects who smoked an average of more than 5 cigarettes per day within 3 months prior to the first administration of the trial drug, or who cannot refrain from using any tobacco products (including nicotine-containing products) during the trial period; 9.(Screening period/admission interview) Subjects with a history of regular alcohol consumption within 6 months prior to the first administration of the trial drug, i.e., consuming more than 14 units of alcohol per week (1 unit equals 17.5 ml or 14 g of pure alcohol; the alcohol content of different types of alcoholic beverages is indicated by volume ratio, and 1 alcohol unit is approximately equivalent to 35 ml of 50% alcohol by volume (ABV) Chinese liquor or 350 ml of 5% ABV beer), or who are unwilling to abstain from alcohol or any alcohol-containing products throughout the trial period; 10.(Screening period/admission interview + online screening) Subjects who have participated in any drug clinical trial and used the trial drug within 3 months prior to admission; 11.(Screening period/admission interview) Subjects who have undergone any surgical operation within 6 months prior to admission or plan to undergo surgery during the trial period; 12.(Screening period interview) Subjects who cannot tolerate venipuncture or have a history of fainting due to needle pricks or blood; 13.(Screening period/admission interview) Subjects who have donated blood or lost 400 ml or more of blood within 3 months prior to admission, or plan to donate blood or blood components during the study period; 14.(Screening period/admission interview) Subjects who have consumed excessive amounts of tea, coffee, or caffeinated beverages (more than 8 cups per day, with 1 cup = 250 ml) within 3 months prior to admission; 15.(Screening period/admission interview) Subjects who have consumed frui
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital Signs;Electrocardiogram ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Indicators; | — |
Countries
China
Contacts
Public ContactYang Guoping
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed