None
Conditions
Interventions
A:10 healthy subjects (half male and half female) will orally take Sishen Pills (9 g) on Day 1 (D1), and blood, urine, and fecal samples will be collected for 48 hours after administration. On Day 8,
Sponsors
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers. Aged between 18 and 35 years. 2. All subjects must weigh more than 50 kg. Their body mass index (BMI) should be between 19 and 24 kg/m² (inclusive). 3. Before the trial, participants must fully understand the procedures, methods, significance, and potential inconveniences of the study. They must be willing to strictly adhere to the clinical trial protocol to complete the study and voluntarily provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Individuals with any clinically significant diseases that affect or have affected the circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, or metabolic systems, or any other conditions that may interfere with the trial results, as well as individuals with physical disabilities. 2. Individuals with abnormal and clinically significant findings in physical examinations, biochemical tests, routine blood/urine/stool tests, electrocardiograms (ECG), chest X-rays, or ultrasound examinations. 3. Individuals with a history of drug dependence, drug abuse, or alcoholism. 4. Individuals known to be allergic or hypersensitive to the components of Psoralea Fructus, Evodia Fructus, Nutmeg, Schisandra Chinensis Fructus, Jujube, Ginger, Coptidis Rhizoma, or the study product, as well as individuals with a general predisposition to allergies. 5. Individuals who have used any medications or foods containing Psoralea Fructus, Evodia Fructus, Nutmeg, Schisandra Chinensis Fructus, or Coptidis Rhizoma within the past week. 6. Individuals who have participated in other drug trials within the past month. 7. Individuals who have used drugs known to cause organ damage within the past 3 months, taken any investigational drugs within the past 4 weeks, or taken any medications within the past 2 weeks. 8. Individuals with a tendency to bleed. 9. Pregnant or breastfeeding women, as well as women of childbearing age who are taking contraceptive medications. 10. Individuals with clinically significant abnormal vital signs. 11. Individuals who regularly consumed alcohol within the 6 months prior to the trial, defined as consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine), or who smoked more than 1 cigarette per day within the 3 months prior to the trial. 12. Individuals who have used soft drugs (e.g., marijuana) within the past 3 months or hard drugs (e.g., cocaine, phencyclidine, etc.) within the past year. 13. Individuals who have used any drugs that inhibit or induce hepatic drug metabolism within the past 30 days (e.g., inducers-barbiturates, carbamazepine, phenytoin, rifampicin, etc.; inhibitors-SSRI antidepressants, cimetidine, cyclosporine, macrolides, verapamil, quinolones, azole antifungals, HIV protease inhibitors, etc.; P-gp inducers, including rifabutin, St. John's wort, oxcarbazepine, modafinil, etc.). 14. Individuals who have donated blood within the past 3 months or experienced blood loss of =400 mL. 15. Individuals with a frequent history or current presence of constipation or diarrhea. 16. Individuals prone to fainting during blood draws (needle phobia), at the sight of blood, or experiencing orthostatic hypotension. 17. Individuals deemed unsuitable for participation in the clinical trial by the investigator for any other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;Urine Concentration;Fecal concentration; | — |
Countries
China
Contacts
Public ContactHu Siyuan
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed