Healthy People
Conditions
Interventions
A group:On the morning of the first cycle D1 administration, under fasting conditions, take orally 100mg (2 tablets, specification: 50mg/tablet) of fluorotinib maleate tablets. After a 10 day cleaning
The subjects took orally 100mg (2 tablets, specification: 50mg/tablet) of fluorotinib maleate tablets 30 minutes (+/- 1 minute) after the start of meals.
B group:Start eating high-fat and high calorie meals 30 minutes before the morning administration of the first cycle D1 medication
The subjects took orally 100mg (2 tablets, specification: 50mg/tablet) of fluorotinib maleate tablets 30 minutes (+/- 1 minute) after the start of meals. After a 10 day cleaning period, the medication
Sponsors
Chengdu Xinhua Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Age and gender: 18 to 45 years old (including 18 and 45 years old), no gender limit; 2. The weight of male subjects is >=50.0 kg, the weight of female subjects is >=45.0 kg, and the body mass index (BMI) is between 19.0 and 25.0 kg/m^2 (including the boundary value); 3. Those who fully understand the trial content, trial drugs, trial process, etc., can communicate well with the researchers, are willing to comply with the research regulations, voluntarily participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. (Screening period consultation/check-in consultation) Those with a history of severe allergies (such as angioedema and anaphylactic shock), allergies (such as allergies to pollen, two or more drugs/foods), or those with Those who are judged by the researcher to have a clinically significant history of food or drug allergies or other allergic diseases (asthma, urticaria, eczematous dermatitis, etc.); or those who are known to be allergic to JAK inhibitors or to excipients contained in the trial drug ; 2. Pre-selection physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (including: blood routine, blood biochemistry, urine routine, blood pregnancy (females only), infectious disease screening, antinuclear antibodies, coagulation function , tuberculosis antibodies, chest anteroposterior X-ray examination, abdominal color ultrasound) results are abnormal and clinically significant; 3. During the screening period, the electrocardiogram showed QTcF > 440 ms for men and QTcF > 460 ms for women; 4. (Screening period consultation/check-in consultation) Those who have undergone major surgical operations within 3 months before screening or plan to undergo surgery during the trial; 5. (Screening period consultation) Those who suffer from acute diseases within 2 weeks before screening; those who have clinically significant infections (such as upper respiratory tract infection, nasopharyngitis, urinary system infection, etc.) within 3 months before screening; those who have any symptoms within 7 days before screening Those with evidence of infection; those with a history of herpes simplex infection or recurrent (>1) herpes zoster or disseminated herpes zoster. 6. (Screening period consultation/check-in consultation) Have any history of serious clinical diseases or diseases or conditions that the researcher believes may affect the test results, including but not limited to the circulatory system, endocrine system, nervous system, digestive system, urinary system or History of blood, immune, psychiatric and metabolic diseases; 7. (Inquiry during the screening period) Those with a history of dysphagia or any gastrointestinal system disease (or gastrointestinal resection, etc.) that affects drug absorption; 8. (Inquiry during the screening period) Those with irregular bowel movements and habitual constipation or diarrhea; 9. (Inquiry during the screening period) Those with a history of lipid metabolism defects, such as: familial hyperlipidemia, lipoid nephropathy, or patients with acute pancreatitis accompanied by hyperlipidemia, etc.; 10. Those whose urine is positive for multiple combined drug tests (including morphine, methamphetamine, ketamine, methylenedioxyamphetamine, and tetrahydrocannabinolic acid); 11. (Screening period consultation/check-in consultation) Those who have a history of drug abuse or drug dependence; 12. (Screening period consultation/check-in consultation) Those who have been vaccinated within 8 weeks before screening, or plan to be vaccinated during the study or within 8 weeks after the administration of study drugs; 13. (Screening period consultation/check-in consultation) Those who have donated blood or lost =400 mL of blood or received blood transfusions within 3 months before screening; or those who have donated blood or blood components within 1 month after the planned trial ends; 14. (Screening period consultation) Those who have special requirements for diet or cannot comply with the unified die
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood sample PK parameters: Tmax, Cmax, t1/2, CL/F, AUC0-t, AUC0-8, Vz/F; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs;Laboratory tests indicators; | — |
Countries
China
Contacts
Public ContactXiaolan Yong
Chengdu Xinhua Hospital
Outcome results
None listed