Healthy subjects
Conditions
Interventions
TR Group:First-cycle oral test formulation (T), second-cycle oral reference formulation (R)
RT Group:First-cycle oral test formulation (R), second-cycle oral reference formulation (T)
Sponsors
The Second Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged between 18 and 55 years old (including 18 and 55 years old); 2. Body mass index (BMI) = weight (kg) / height^2 (m^2), with a BMI range of 19.0 to 28.0 (including the critical values); male subjects should have a weight of >=50.0 kg, and female subjects should have a weight of >=45.0 kg; 3. According to medical history, vital signs, 12-lead electrocardiogram, physical examination, and laboratory test results, all are normal or without clinical significance (as judged by the investigator); 4. Subjects should be willing to take effective contraceptive measures during the period of taking study drugs until 3 months after stopping the drug to avoid pregnancy or causing pregnancy in their partners; 5. Subjects must fully understand and strictly adhere to the research process, voluntarily participate, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Individuals with a history of clinically significant drug allergies (especially those known or suspected to be allergic to sodium valproate or its excipients) or atopic allergic diseases (such as asthma, urticaria, eczematous dermatitis, etc.) or severe allergic constitution (known to be allergic to three or more drugs or foods); 2. Those with severe systemic diseases, such as respiratory, blood, endocrine, cardiovascular and cerebrovascular, nervous system, immune, urinary, digestive tract, liver, kidney, and metabolic abnormalities, mental disorders, or any other disease or physiological condition that may affect the research results; 3. Individuals who have a history of drug abuse, excessive use of drugs, or drug dependence within 5 years before screening, or those who test positive for substance abuse; 4. Heavy drinkers or those who regularly consume alcohol within 6 months before screening, i.e., consuming an average of more than 14 units of alcohol per week (1 unit = 17.7 mL ethanol, which is equivalent to 357 mL of beer with 5% alcohol content or 43 mL of liquor with 40% alcohol content or 147 mL of wine with 12% alcohol content) or those who test positive for alcohol breath analysis during screening; 5. Smokers or those who smoke an average of more than 5 cigarettes per day within 3 months before screening; 6. Those who have consumed excessive amounts of tea, coffee, or caffeine-containing beverages (more than 8 cups per day, 1 cup = 250 mL) within 3 months before screening; 7. Individuals who have donated blood or suffered from significant blood loss (>400 mL) within 3 months before screening, received blood transfusions or blood products, and plan to donate blood within one month after the trial ends; 8. Those who have used prescription drugs, non-prescription drugs, health products including Western medicine or Chinese herbal medicines within 2 weeks before the trial, especially monoamine oxidase inhibitors such as moclobemide, tricyclic antidepressants, benzodiazepines, antipsychotics, anticonvulsants, lithium salts, serotonergic agents, tryptophan, anticoagulants; 9. Individuals who have used any drugs that inhibit or induce hepatic drug metabolizing enzymes within 4 weeks before the trial (e.g.: CYP2D6 inducers - phenobarbital etc.; CYP2D6 potent inhibitors - such as antidepressants amitriptyline, desipramine etc., analgesics methadone, antihistamines azatadine, promethazine etc., antipsychotic drugs chlorpromazine, clozapine, risperidone etc., cardiovascular drugs amiodarone, nicardipine, propafenone etc.); 10. Female subjects who are breastfeeding or have a positive pregnancy result during the screening period or during the trial; 11. Those who develop acute illnesses during the pre-study screening phase or before randomization; 12. Individuals with special dietary requirements who cannot adhere to a unified diet; 13. Those experiencing difficulty in swallowing; 14. Individuals with a history of syncope upon seeing blood/needles and cannot tolerate venous indwelling blood collection; 15. Participants who have participated in other clinical trials within 3 months before this trial; 16. Subjects who may not be able to complete this study due to other reasons or are deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Plasma Concentration Cmax;Area Under the Curve AUC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Maximum Plasma Concentration;Elimination Half-life; | — |
Countries
China
Contacts
Public ContactZhiqing Zhang
The Second Hospital of HeBei Medical University
Outcome results
None listed