None listed
Conditions
Interventions
Sponsors
Wuhan Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) The subjects have a full understanding of the purpose, nature, and methods of the trial, as well as the possible adverse reactions. They volunteer to be subjects and sign the informed consent form before the start of the research procedure. (2) Healthy male and female subjects aged between 18 and 65 years old (both 18 and 65 years old are included). (3) For males, the body weight is >= 50.0 kg; for females, the body weight is >= 45.0 kg. The body mass index (BMI) is within the range of 19.0 to 27.0 kg/m² (including the critical values). (4) The systolic blood pressure (sitting position) is between 90 mmHg and less than 140 mmHg, the diastolic blood pressure (sitting position) is between 60 mmHg and less than 90 mmHg. The pulse rate is between 55 beats per minute and 100 beats per minute, and the body temperature is normal (the ear temperature is between 35.5°C and 37.5°C).
Exclusion criteria
Exclusion criteria: (1) (Inquiry) Those with a history of allergy to Piracetam Tablets or any of the drug components; or those with an allergic constitution, such as those allergic to one or more drugs, foods; or those with a history of allergy to drugs of the same class. (2) (Inquiry) Those who have undergone surgery within 3 months before screening, or those who plan to undergo surgery during the research period, and those who have undergone any surgery that may affect the absorption, distribution, metabolism, and excretion of the drug. (3) (Inquiry) Those with clinically abnormal manifestations that need to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidneys, liver, gastrointestinal tract, respiratory system, metabolism, and skeletal system, etc. (4) Those with abnormal physical examination results, chest frontal radiograph results, 12-lead electrocardiogram results, or laboratory examination results (judged to be of clinical significance by a clinician). (5) Those with positive results in one or more of the tests for human immunodeficiency virus antibody (HIV-Ab), quantitative hepatitis B surface antigen (HBsAg), quantitative hepatitis C virus antibody (Anti-HCV), and specific antibody to Treponema pallidum (Anti-TP). (6) (Inquiry) Those who smoke more than 5 cigarettes per day within 3 months before screening, or those who do not agree to avoid using any tobacco products during the trial. (7) (Inquiry) Those who consume excessive amounts of tea, coffee, and/or caffeine-rich beverages (more than 8 cups, 1 cup = 250 mL) per day within 3 months before screening, or those who do not agree to avoid using any tea, coffee, and/or caffeine-rich products during the trial. (8) (Inquiry) Those who consume more than 14 units of alcohol per week within 3 months before screening (1 unit of alcohol ˜ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine), or those who do not agree to avoid using any alcoholic products during the trial. (9) (Inquiry) Those with special dietary and/or exercise factors before the trial that may affect the absorption, distribution, metabolism, and excretion of the drug during the trial, including but not limited to those who have consumed special diets that may affect drug metabolism (including dragon fruit, mango, grapefruit, lime, carambola, chocolate or foods or beverages prepared from them, or diets containing caffeine, xanthine, etc.) within 7 days before screening; or those who do not agree to avoid strenuous exercise within 48 hours before the trial. (10) (Inquiry) Those who have donated blood or lost blood >= 200 mL within 3 months before screening, or those who plan to donate blood (including blood components) during the trial or within 3 months after the end of the trial. (11) Pregnant women, lactating women, or women of childbearing age with a positive urine pregnancy test result during screening, and those who do not agree to take effective contraceptive measures during the trial or whose spouses plan to have a baby within 3 months. (12) (Inquiry) Those who have taken any drugs (including traditional Chinese medicines, functional vitamins, health products, prescription drugs, over-the-counter drugs) that the researcher deems may affect the evaluation of the pharmacokinetic characteristics of the research drug within 2 weeks before screening. (13) (Inquiry) Patients with extrapyramidal diseases, Huntington's
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the maximum plasma concentration;the areas under the plasma concentration–time curve ;AUC0-8;Tmax;t1/2; | — |
Countries
China
Contacts
Public ContactZhou Ming
Wuhan Pulmonary Hospital
Outcome results
None listed