A Bioequivalence Study of Olanzapine Samidofen Tablets in Healthy Subjects Under Fasting Conditions.

Who cannot join

• 1)There are cardiovascular system, liver, kidney, gastrointestinal tract, nervous system, immune system, endocrine system, respiratory system.Serious medical history such as system and mental disorders, which the research doctor deems unsuitable for participants; 2)Abnormal conditions with clinical significance judged by clinical physicians, including physical examination, vital sign examination, electrocardiogram or clinical laboratory tests, etc.
• 3)Individuals with a specific history of allergies (asthma, etc.) or current allergic diseases (urticaria, eczema, etc.), or an allergic constitution(For those who are allergic to two or more drugs, foods such as milk or pollen), or known to be allergic to the components of this drug or similar substancesIndividuals with allergies to certain substances; 4)History of swallowing difficulties or any gastrointestinal diseases that affect drug absorption (such as gastrectomy or small bowel resection, atrophic gastritis)Patients with inflammation, gastrointestinal bleeding, obstruction, etc; 5)Individuals with abnormally elevated blood lipids, or hyperglycemia and/or diabetes, or a history of hypertension or hypotension, or a history of orthostatic hypotension or syncope, or a history of hyperprolactinemia, or clinically significant leukopenia and/or neutropenia, or a history of epilepsy or convulsions.
• 6)Individuals with angle-closure glaucoma or a tendency towards angle-closure glaucoma.
• 7)Female subjects who are currently pregnant, breastfeeding, or have a positive pregnancy test result; 8)Hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody, any one or more of which is positiveThe person; 9)Individuals with a history of drug abuse within the past five years, or those who have used drugs within the past three months prior to screening, or those who have tested positive for drugs in their urine; 10)Drinking an average of over 14 units of alcohol per week within the first 3 months of screening (1 unit=360 mL of beer or 45 mL)For those who drink 40% alcohol or 150 mL wine, or from 24 hours before taking the medication to the completion of the cycleIndividuals who cannot stop alcohol intake during blood sample collection, or those who test positive for alcohol breath test; 11)Screening for individuals who have smoked an average of more than 5 cigarettes per day within the past 3 months or have refused to use tobacco products during their stay; 12)Screening for individuals with a history of surgery within the previous 3 months or those planning to undergo surgery during the study period; 13)Individuals who have donated blood or experienced significant blood loss (>400mL, excluding physiological blood loss in females) within 3 months prior to their first medication, orIndividuals who donate ≥ 2 therapeutic doses of platelets within a month (1 therapeutic dose=12U platelets).
• 14)Individuals who have participated in any drug or device clinical trial and received medication or device treatment within 3 months prior to their first medication; 15)Individuals who have used any opioid drugs (including but not limited to morphine, oxycodone, codeine, hydrocodone, compound licorice tablets, etc.) or any drugs that inhibit or induce hepatic enzymes (such as inducers-barbiturates, entecavir, phenytoin, glucocorticoids, carbamazepine; inhibitors-SSRI antidepressants, fluvoxamine, cimetidine, omeprazole, diltiazem, verapamil, macrolides, nitroimidazoles, sedative-hypnotics, fluoroquinolones, antihistamines) within 30 days before the first dose; 16)Individuals who have used any prescription drugs or received vaccinations within 14 days before the first dose.
• 17)Individuals who have used any over-the-counter drugs, herbal medicines, or health supplements within 7 days prior to their first medication; 18)Have taken a special diet (such as grapefruit and products containing grapefruit) within 48 hours before the first dose, or anyA diet rich in xanthine like substances (such as coffee, tea, chocolate, cocoa, milk tea, etc.) may have intense physical activity.Movement or other factors that affect drug absorption, distribution, metabolism, excretion, etc; 19)Individuals with difficulty in venous blood collection or a history of needle and blood dizziness; 20)Those who have special dietary requirements and cannot comply with the provided diet and corresponding regulations; 21)Other potential participants deemed ineligible by the investigators or those who are unable to participate in the trial for personal reasons.