RCC
Conditions
Interventions
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions; 2) to be able to complete the study in accordance with the requirements of the trial program; 3) Subjects (including male subjects) are willing to take no pregnancy plan within the next 6 months and voluntarily take effective contraceptive measures, see Appendix for specific contraceptive measures; 4) healthy subjects aged 18 to 65 years (including 18 and 65 years); 5) male subjects weighing no less than 50 kg, female subjects weighing no less than 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index in the range of 18 to 28 (including the critical value); 6) health: heartless, liver, kidney, digestive tract, nervous system, mental disorders and metabolic abnormalities and other medical history; 7) physical examination of normal or abnormal no clinical significance.
Exclusion criteria
Exclusion criteria: 1) more than 5 cigarettes per day for the first 3 months of the trial; 2) have an allergy history for everolimus or its excipients; 3) Have a history of drug and / or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits, or 1 cup of wine); 4) Blood donation or extensive blood loss (> 450 mL) within three months before taking the study drug; 5) have difficulty swallowing or any history of gastrointestinal disease that affects the absorption of drugs; 6) suffering from any increased risk of hemorrhagic disease, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers; 7) taking any drug that changes liver enzyme activity 28 days before taking the study drug; 8) taking any prescription drugs, non-prescription drugs, any vitamin products or herbs within 14 days prior to taking the study drug; 9) 2 weeks before the test took a special diet (including dragon fruit, mango, grapefruit, and / or xanthine diet, etc.) or strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors; 10) inhibitors or inducers of the following CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone; 11) have recently made significant changes in diet or exercise habits; 12) taking the research drug within three months before taking the study medication, or taking the drug clinical trial; 13) ECG abnormalities have clinical significance; 14) Clinical laboratory tests are clinically significant, or other clinical findings showing clinically significant diseases (including but not limited to gastrointestinal, renal, liver, nerv15) hepatitis (including hepatitis B and hepatitis C), AIDS, syphilis screening positive; 16) acute disease before the study of the screening stage or before the study; 17) Chocolate intake, any caffeine, or xanthine-containing food or drink 48 hours before taking the study drug; 18) taking any alcoholic products within 24 hours prior to taking the study; 19) Female subjects are in lactation or serum pregnancy outcomes during screening or during the trial; 20) alcohol and drug screening positive or drug abuse history over the past five years or 3 months before the trial.es, blood, endocrine, neoplasms, lungs, immune, mental or heart Cerebrovascular disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactYanhua Ding
The First Hospital of Jilin University
Outcome results
None listed