cancer
Conditions
Interventions
1:selatinib 50mg
2:selatinib 100mg
3:selatinib 200mg
4:selatinib 250mg
5:selatinib 300mg
6:selatinib 350mg
7:selatinib 500mg
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be selected: 1) Gender: male or female; 2) Age: between 18 and 40 years old, the difference between the same batch age is not more than 10 years old; 3) Weight: female weight is greater than 45 kg, male weight is greater than 50 kg, and the subject's body mass index (BMI) is between 19 and 24 kg / m2 (including the boundary value); 4) Subjects must give informed consent to the study before the trial and voluntarily sign a written informed consent form; 5) The subject can communicate well with the researcher and complete the research according to the research regulations.
Exclusion criteria
Exclusion criteria: 1) Patients with clinically significant disease or surgery within 4 weeks before the trial; 2) Those who are clearly allergic to this product or any of its accessories; 3) Anyone with a history of serious clinical disease or history of circulatory system, endocrine system, nervous system disease or hematology, immunology, psychiatric disease and metabolic abnormality; 4) Patients with gastrointestinal, liver, and kidney diseases that can affect drug absorption or metabolism; 5) Laboratory examination (blood routine, urine routine, blood biochemical examination, etc.) found abnormal clinical diagnosis significance; 6) those whose liver function tests exceed the normal range; 7) Those with abnormal ECG (with clinical significance) or vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm); 8) HIV positive; 9) Hepatitis B surface antigen test or hepatitis C test; 10) Alcoholics or frequent drinkers within 6 months before the test, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL of 40% spirits or 150 mL of wine); 11) Smokers or those who smoked more than one cigarette in the 3 months before the test, or who used any tobacco products during the test; 12) Drug abusers or those who used soft drugs (such as cannabis) 3 months before the test or who took hard drugs (such as cocaine, phencyclidine, etc.) one year before the test; 13) Anyone who is allergic to food or has special requirements for diet, who cannot follow a unified diet; 14) Those who drink excessive amounts of tea, coffee and / or caffeinated beverages (more than 8 cups) per day; 15) Any drug that inhibits or induces liver drug metabolism (such as: inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; 30 days before or during the test) SSRI antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); 16) Those who have taken any drugs within 14 days before the trial; 17) Those who have taken any clinical trial drugs or participated in any clinical trials of drugs within 30 days before the trial; 18) Blood donation or sampling as a subject 3 months before the test; 19) Subjects may be unable to complete the study for other reasons or those the investigator believes should not be included; In addition to the above requirements for female subjects, those who meet the following conditions should also be excluded; 20) Those who took oral contraceptives 30 days before and during the trial; 21) Those who used long-acting estrogen or progestin injections or implants within 6 months before and during the trial; 22) Unprotected sexual intercourse with a partner within 14 days before and during the test; 23) Those who are in the menstrual cycle during the test; 24) Women during pregnancy and lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of selatinib and lapatinib; | — |
Countries
China
Contacts
Public ContactGuo-Ping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed