hepatic carcinoma
Conditions
Interventions
Experimental group:Melaleuca Paper Sheet
Control Group:placebo
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Fully understand the purpose, nature, method and possible adverse reactions of this trial, volunteer as a subject, and sign the informed consent (ICF) before any research procedure begins, and guarantee that any procedure will involve myself in the research ; 2. Healthy adult male and female subjects over 18 years old (including 18 years old), with a sex (male:female) ratio of 1:1 (except for study 1 group 1); 3. Female weight >= 45.0kg, male weight >= 50.0kg, body mass index (BMI) within the range of 18.0-26.0 kg/m2 (including boundary values); body mass index (BMI) = weight (kg) / height 2 (m2) ; 4. Based on the detailed medical history, complete physical examination, vital signs examination, laboratory examination, electrocardiogram, chest radiograph, and abdominal B-ultrasound examination results showing no abnormality or abnormality without clinical significance; subjects who are judged by the investigator to be in good health ; 5. The subjects voluntarily take effective contraceptive measures from the screening period to 6 months after the end of the study, of which non-drug contraceptive measures should be used voluntarily during the trial period; and the subjects have no pregnancy from the screening period to 6 months after the end of the study , sperm donation, egg donation plan; 6. The subjects can communicate well with the researcher, voluntarily and can comply with the restrictions and procedures of the research, and accept hospitalization for observation.
Exclusion criteria
Exclusion criteria: 1. Have a history of clinically significant chronic diseases or serious diseases of the cardiovascular, liver, kidney, respiratory, blood and lymphatic, endocrine, immune, mental, neurological, gastrointestinal systems, etc.; 2. Those with a history of specific allergies, or allergies (such as those who are allergic to two or more drugs, foods such as milk and pollen), or those who are known to be allergic to the components or analogs of this drug; 3. A history of dysphagia or any gastrointestinal disease that affects drug absorption; 4. Those who cannot tolerate venipuncture, and those who have a history of fainting and bleeding; 5. Those who have special requirements for diet and cannot comply with the provided diet and corresponding regulations; 6. Those who have a pregnancy plan during the entire trial period and the next 6 months, are unwilling to take one or more non-drug contraceptive measures (such as complete abstinence, contraceptive ring, partner ligation, etc.) Those who have sperm or egg donation plans during and within 6 months after the end of the study; 7. Those who have a history of drug abuse within 6 months before screening, or who have used drugs within 3 months before screening; 8. Those who smoked more than 5 cigarettes per day within 3 months before screening, or who could not stop using any tobacco products during the trial; 9. Those who regularly drink alcohol (more than 14 standard units per week, 1 standard unit contains 14g alcohol, such as 360mL beer or 45mL spirits with an alcohol content of 40% or 150mL wine) within 3 months before screening, or have been drinking heavily ( That is, men who drink more than 28 standard units per week and women who drink more than 21 standard units per week), or those who cannot abstain from alcohol during the trial; 10. Those who donated blood, including blood components or massive blood loss (>=200mL), received blood transfusion or used blood products within 3 months before screening; 11. Those who have undergone surgery within 3 months before screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that may affect drug absorption, distribution, metabolism, and excretion; 12. Those who drink too much tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup = 250 mL), food or beverages rich in xanthine, etc., within 3 months before screening, affect drug absorption and distribution , metabolism and excretion of special dieters; 13. Those who have participated in clinical trials of other drugs and used experimental drugs within 3 months before screening; 14. Those who have been vaccinated within 1 month before screening or plan to be vaccinated during the study; 15. Have used any drugs that affect the activity of liver drug enzymes, such as chlorpromazine, phenylbutazone, etc., within 1 month before screening; 16. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines and dietary supplements/health care (including vitamins, etc.) within 14 days before screening; 17. Excessive consumption of dragon fruit, mango, grapefruit, lime, star fruit or food or drink prepared therefrom within 7 days before screening; 18. For patients with clinically significant abnormal vital signs, refer to the normal range (including the critical value): systolic blood pressure 90~139mmHg in sitting position, diastolic blood pressure 60~89mmHg, pulse rate in sitting position 60~100 beats/m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety indication;Pharmacokinetic Indicators; | — |
Countries
China
Contacts
Public ContactZhang Jianliang
Shanghai Public Health Clinical Center
Outcome results
None listed