Patients with inoperable advanced renal cell carcinoma, treated with inoperable or distant metastatic hepatocellular carcinoma, and progressive radioiodine-refractory differentiated thyroid carcinoma
Conditions
Interventions
TRR group:One test preparation, one reference preparation and one reference preparation shall be taken successively in each cycle
RTR group:Take reference preparation, test preparation and reference preparation one piece each cycle in turn
RRTgroup:One piece of reference preparation, reference preparation and test preparation shall be taken successively in each cycle
Sponsors
Huzhou Central Hospital, Zhejiang Province
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Healthy subjects aged 18 years or older Weight =50 kg (male), =45 kg (female), BMI 19-26 kg/m2; No fertility plan or egg/sperm donation plan within 6 months from the start of the trial to the last dose, and voluntarily take effective contraceptive measures; Subjects fully understand the test content and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) People who are allergic to sorafenib or its excipients or are allergic to them (such as allergic to two or more drugs, foods or pollens); 2) Patients with the following diseases that have clinical significance, including but not limited to respiratory system, circulatory system, digestive system, blood system, endocrine system, immune system, skin system, psychiatric system, ent system and other related diseases; 3) any pre-existing medical condition that significantly increases the risk of bleeding, such as acute gastritis or active ulcers with bleeding, clinically significant thrombocytopenia or anemia, and 4) active pathological bleeding or a history of intracranial bleeding; 5) Have dysphagia or any history of gastrointestinal, liver and kidney diseases that affect drug absorption and metabolism; 6) Patients who have any history of surgery or trauma that may affect the safety of the trial or the process in vivo of the drug, or who plan to have surgery during the study; 7) Those who have a history of drug abuse or have used drugs within 3 months before screening; 8) Excessive consumption of tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup =250 ml) per day in the 3 months prior to screening, or unable to interrupt during the trial; 8) Those who smoked more than 5 cigarettes per day in the 3 months before screening, or could not stop using any tobacco products during the test period (from screening to the end of the test); 9) Those who consumed an average of more than 14 units of alcohol per week (1 unit alcohol ˜360mL beer or 45mL liquor with 40% alcohol or 150mL wine) in the 6 months prior to screening, or who could not refrain from alcohol during the test period; 10) Blood donation including component blood or substantial blood loss (=400mL) within 3 months prior to screening, blood transfusion or use of blood products, or planned blood donation during the trial; 11) Any drug that inhibits or induces liver metabolism of drugs (such as CYP3A4 inducer -- rifampicin, hypericum perforatum, phenytoin, carbamazepine, phenobarbital, dexamethasone, neomycin, etc.) has been used within 28 days before screening; 12) Use of any prescription drugs, over-the-counter drugs, Chinese herbs and health products within 14 days before screening; 13) Participating in other drug clinical trials or participating in clinical investigators other than yourself within 3 months before screening (the last visit time of the last trial is calculated as the start time); 14) Those who were vaccinated within 1 month prior to screening or planned to be vaccinated during the study period; 15) Patients who cannot tolerate venipunction and have a history of fainting needles and blood; 16) Those who have special dietary requirements and cannot accept a unified diet; 17) Vital signs, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function, infectious disease screening), electrocardiogram, whose results show abnormal clinical significance; 18) Alcohol breath test results greater than 0mg/100mL; 19) Positive urine drug screening results (morphine, methamphetamine, ketamine, dimethylene dioxyamphetamine, THC, cocaine); 20) Female subjects are pregnant or breastfeeding, or have positive pregnancy results; 21) The investigator believes that it is not appropriate to participate in clinical studies or cannot complete the study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C max;AUC 0-t;AUC 0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| T max;? z;t 1/2;AUC _%Extrap; | — |
Countries
China
Contacts
Public ContactYang Shuixin
Huzhou Central Hospital, Zhejiang Province
Outcome results
None listed