hepatocellular carcinoma
Conditions
Interventions
treatment group:Subjects will have breakfast on Day 1 of the trial, finish eating within 30 minutes, and take the drug 30 minutes after the meal
6 icaritin soft capsules will be swallowed with 240 mL warm water
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Eligibility requires all following conditions: 1) Healthy adult male; 2) Age: 18–45 years (inclusive); 3) Weight: Body mass index (BMI) 19–26 kg/m^2 (inclusive); 4) Voluntary signed informed consent; 5) Ability to communicate effectively with researchers and comply with protocol requirements
Exclusion criteria
Exclusion criteria: Exclusion applies to any of the following conditions: 1) Clinically significant abnormal results in laboratory tests (blood routine, urine routine, stool routine, blood biochemistry, coagulation function) as judged by the investigator; 2) Clinically significant abnormal ECG findings during screening; 3) Clinically significant abnormal chest X-ray findings during screening; 4) Clinically significant abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) as judged by the investigator; 5) Positive hepatitis B surface antigen or hepatitis C antibody test; 6) Positive human immunodeficiency virus (HIV) antibody test; 7) Positive syphilis test; 8) Use of any liver enzyme inducer/inhibitor within 30 days before screening (inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors: SSRIs, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives/hypnotics, verapamil, fluoroquinolones, antihistamines); 9) Use of any medication within 14 days before screening; 10) Participation in any clinical trial or use of investigational drugs within 3 months before screening, or planned participation in another clinical trial within 1 month after trial completion; 11) History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsades de pointes, ventricular tachycardia, QT prolongation syndrome, or family history of QT prolongation syndrome (evidenced by genetic proof or sudden cardiac death in young relatives); 12) Undergoing major surgery within 6 months before screening; 13) History of severe clinical diseases, including but not limited to cardiovascular, endocrine, nervous, digestive, urinary, hematological, immune, psychiatric, metabolic diseases, or a history of cancer; 14) History of allergic constitution, including confirmed allergy to flavonoid drugs or any excipients, food components, or special dietary requirements that prevent compliance with the unified diet; 15) History of hematological diseases such as coagulation disorders; 16) Habitual constipation; 17) Alcoholism or frequent drinking (>= 14 units of alcohol per week within 6 months before screening, where 1 unit = 360 mL beer, 45 mL 40% spirits, or 150 mL wine); 18) Nicotine addiction or smoking >5 cigarettes daily within 3 months before screening, with inability to quit during the trial; 19) History of drug abuse, use of soft drugs (e.g., marijuana) within 3 months before screening, use of hard drugs (e.g., cocaine, amphetamines, PCP) within 1 year before screening, or positive urine drug test during screening; 20) Habitual consumption of grapefruit juice, excessive tea, coffee, and/or caffeinated beverages, with inability to quit during the trial; 21) Planning to conceive during the trial or within 3 months after trial completion, or refusal to use strict contraceptive measures for the subject and spouse during the trial and within 3 months after completion (specific measures see Appendix 1); 22) History of blood loss or blood donation >= 200 mL within 3 months before screening, or planned blood donation within 1 month after trial completion; 23) Subjects unlikely to complete the study for other reasons, or deemed ineligible by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactYuan Weian Zhu Leilei
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed