Study on the Bioequivalence of Amisulpride Orally Disintegrating Tablets in Human Body

Inclusion Criteria:

• 1. Chinese male or female subjects aged ≥ 18 years old (including 18 years old);

2. Weight: Male ≥ 50 kg, female ≥ 45 kg, and body mass index (BMI) between 19.0 and 26.0 kg/m2 (including boundary values, BMI=weight (kg)/height 2 (m2));
3. During the screening period, the vital signs, physical examination, laboratoryexamination, and electrocardiogram of the subjects were found to be normal orabnormal, and were determined by the researchers to be clinically insignificant;
4. All fertile subjects agree to take appropriate and effective physical contraceptionmeasures for themselves and their partners from the screening period (female subjectsfrom 2 weeks before screening) to the end of the experiment, and to take effectivephysical contraception and/or medication contraception measures within 6 months afterthe end of the experiment, without any plans for sperm or egg donation;
5. The subjects fully understand the purpose, nature, and potential adverse reactionsof the experiment, understand and follow the research process, voluntarilyparticipate, and sign an informed consent form;
6. Those who are able to communicate well with researchers and understand and complywith the requirements of this study.

Exclusion Criteria:

• 1. Those with a past or existing history of the following diseases or chronic/severeillnesses, including but not limited to the cardiovascular system, digestive system,urogenital system, respiratory system, blood system, endocrine system, immune system,mental nervous system, skeletal system, etc., that researchers believe are stillclinically significant; Especially for subjects with gastrointestinal dysfunction,peptic ulcer, gastrointestinal surgery, and other diseases that affect drugabsorption, distribution, metabolism, and excretion;

2. Screening subjects who have undergone surgery within the first 3 months, or whoplan to undergo surgery during the study period, or who have undergone surgery thataffects drug absorption, distribution, metabolism, and excretion;
3. There is a history of food and drug allergies that researchers have determined tobe clinically significant; Or known allergies to sulfamethoxide or its excipients, ora history of other allergic diseases (asthma, urticaria, eczema dermatitis);
4. Previous or existing history of vascular edema or peripheral edema;
5. Screening for individuals with blurred vision, visual abnormalities, diplopia, orfundus lesions within the first 14 days; 6. Individuals with oral diseases such asoral ulcers during the screening period;
6. Previous or existing xerostomia patients;
7. People with positive results of any test for human immunodeficiency virus (HIV)antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody ortreponema pallidum antibody (TP Ab);
8. Screening for individuals with a history of drug abuse or positive urine drug abusescreening within the previous 12 months;
9. Regular drinkers within the first 6 months of screening, i.e. those who consume anaverage of more than 14 units of alcohol per week (1 unit ≈ 285 mL of beer with analcohol content of 3.5%, 25 mL of spirits with an alcohol content of 40%, or 85 mL ofwine with an alcohol content of 12%), or those who cannot dispose of alcohol 48 hoursbefore administration until the end of the study, or those who have tested positivefor alcohol breath during the screening period; 11. Smoking an average of more than 5cigarettes per day in the first 3 months of screening; Or those who cannot give upsmoking 48 hours before administration until the end of the study;
10. Receive blood transfusion or use blood products within 3 months before screening;Those who have donated blood or experienced significant bleeding (greater than 400 mL,except for blood loss during normal physiological periods in females) within 3 monthsbefore the first administration, or plan to donate blood or blood components duringthe study period or within 1 week after the end of the study;
11. Screening subjects who have participated or are currently participating in otherclinical trials within the first 3 months (drug clinical trials are defined as thosewho have used clinical research drugs);
12. Screening subjects who have used any prescription drugs, over-the-counter drugs,Chinese herbal medicines, health products, and functional vitamins within the previous 14 days; Or those who have received vaccines within 2 weeks before screening or thosewho have vaccination plans during the trial period;
13. Those who have special dietary requirements, cannot accept a unified diet, andcomply with corresponding regulations; Or those who consume beverages (coffee, tea) orfood (animal liver) rich in xanthine during the experiment, or consume fruits or juicesuch as grapefruit, grapefruit, mango, etc. that may affect drug metabolism;
14. Individuals with rare genetic diseases such as lactose or galactose intolerance,primary lactase deficiency, or glucose galactose malabsorption; 17. Pregnant orlactating female subjects; Female reproductive age subjects who engage in sexualactivity without effective contraceptive measures within 14 days prior to signing theinformed consent form;
15. Those with difficulty swallowing;
16. Patients with poor vascular puncture conditions, inability to tolerate venouspuncture, or those with needle and blood fainting;
17. Other subjects deemed unsuitable by the researchers to participate in the study.