None listed
Conditions
Interventions
Experimental group:Cellular Sodium Cytidine Diphosphate Choline Tablets, 0.2 g, administered orally in the fasting state.
Sponsors
Wuhan Zijing Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.Subjects who are willing and able to comply with the protocol requirements, have been fully informed of the nature, purpose, procedures, and potential risks of the study, and have voluntarily signed the informed consent form (ICF); 2.Subjects who agree to have no plan for conception or sperm donation from signing of the ICF until 6 months after the last dose, and who agree to use highly effective contraceptive methods as specified in the protocol (see Appendix 4) during this period; 3.Healthy male subjects aged 18 to 50 years, inclusive; 4.Male subjects weighing =50 kg, with a Body Mass Index (BMI) between 19.0 and 27.0 kg/m², inclusive (BMI = weight (kg) / height² (m²)).
Exclusion criteria
Exclusion criteria: 1.Subjects with any clinically significant abnormality in physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory tests at screening. 2.Subjects with a history of clinically significant cardiovascular, endocrine, neurological, respiratory, hematological, immunological, or psychiatric disorders, or significant metabolic abnormalities, which, in the investigator's judgment, would make the subject unsuitable for participation in the study. 3.Subjects with a history of dysphagia, peptic ulcer disease, gastrointestinal (GI) bleeding, or any other gastrointestinal disorder that may affect drug absorption (e.g., gastrectomy, small bowel resection, atrophic gastritis, GI obstruction, diarrhea, etc.). 4.Subjects with known hypersensitivity to the active ingredient, any excipients of the formulation, or with a history of other clinically significant drug or food allergies. 5.Subjects with lactose intolerance (e.g., a history of diarrhea after consuming milk or dairy products); 6.Subjects with a history of syncope or vasovagal reactions related to venipuncture or blood sampling (e.g., fainting at the sight of blood or needles), or those intolerant to serial venous punctures; 7.Subjects with special dietary requirements or those unable to comply with the standardized meals provided during the study. 8.Subjects who have used any prescription medications, over-the-counter (OTC) drugs, traditional Chinese medicine (TCM), vitamins, or health supplements within 2 weeks prior to screening; 9.Subjects with a history of excessive intake of xanthine-containing drinks (coffee, tea, cola) or grapefruit-related products (grapefruit, dragon fruit, mango) within 14 days before screening. 10.Subjects with any vaccination within 14 days before screening or scheduled to be vaccinated during the study. 11.Subjects who used potent CYP450 enzyme inducers (e.g., barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) or inhibitors (e.g., SSRIs, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives, verapamil, fluoroquinolones, antihistamines) within 30 days prior to screening. 12.Subjects who have used any meclofenoxate (centrophenoxine / meclofenoxate hydrochloride) preparations (e.g., Meclofenoxate Hydrochloride Capsules, Meclofenoxate Hydrochloride Tablets, Meclofenoxate Hydrochloride Injection) within 30 days prior to screening. 13.Subjects who have participated in any other clinical trial and received an investigational product (study drug) within 3 months prior to screening. 14.Subjects who have had a cumulative blood loss =400 mL within 3 months prior to screening, or who plan to donate blood during the study period. 15.Subjects with an average daily cigarette consumption >5 within 3 months before screening, or unwilling to refrain from tobacco use during the study. 16.Subjects who, within 3 months prior to screening, regularly consume alcohol exceeding 14 units per week (1 alcohol unit = 14 g ethanol ˜ 360 mL beer, or 45 mL distilled spirits [40% v/v], or 150 mL wine), or who are unwilling to abstain from alcohol or any alcohol-containing products during the study period, or with a positive breath alcohol test at screening. 17.Subjects who, within 3 months prior to screening, regularly consume excessive amounts of tea, coffee, and/or other caffeine-containing beverages (>8 cups/day; 1 cup = 250 mL), or who are unwilling to abstain from caffeine-containing products during the study period. 18.Subje
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve from time zero to infinity (AUC-8);Area under the plasma concentration-time curve from time zero to the last measurable concentration time t (AUC-t);Peak plasma concentration (Cmax); | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of extrapolated AUC (AUC_% Extrap);Terminal elimination rate constant (?z);Time to peak concentration (Tmax);Elimination half-life (t?/?);Adverse events; | — |
Countries
China
Contacts
Public ContactZhou Songbo
Wuhan Zijing Hospital
Outcome results
None listed