hematological malignancies
Conditions
Interventions
Group A:Fasting
Group B:Low-fat meal
Group C:High-fat meal
Sponsors
The Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Volunteers must give informed consent to the trial before the trial, fully understand the trial content, process and possible adverse reactions, and voluntarily sign a written informed consent; 2. The volunteers can communicate well with the researchers and complete the trial according to the protocol; 3. Gender: female; 4. Aged over 18 years (including 18 years old); 5. Female volunteers weighing >=45kg, and body mass index (BMI) between 19.0 and 26.0 kg/m^2, BMI=weight (kg)/height (m^2), including boundary values.
Exclusion criteria
Exclusion criteria: 1. Those who have suffered or are currently suffering from any serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry and metabolic abnormalities or any other disease that could interfere with the test results; 2. A history of allergies to drugs, food or other substances; 3. Those who have undergone surgery within 4 weeks before the trial, or who plan to undergo surgery during the study; 4. Those who have taken any drugs or health products (including Chinese herbal medicine) within 14 days before the test; 5. Use of any drug that inhibits or induces hepatic metabolism of the drug within 30 days prior to the test (eg: inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitorsSSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 6. Subjects refuse to stop any special diet 7 days before the first dose until the end of the study (including grapefruit, chocolate, tea, cola, or any caffeinated food or beverage, alcoholic beverage or other food or beverage that affects drug absorption, distribution, metabolism, and excretion); 7. Those who participated in any clinical trial and took any clinical trial drug within 3 months before the trial; 8. Those who donated blood or lost a large amount of blood (>=200 mL, excluding menstrual blood loss in women), received blood transfusion or used blood products within 3 months before enrollment; 9. Lactating and pregnant subjects, and female subjects of childbearing age who cannot use one or more non-drug contraceptive measures during the trial and at least 6 months after the last dose; 10. Those who have special requirements for diet and cannot comply with the unified diet; 11. Those who drink too much tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day; 12. Smokers or those who smoked more than 5 cigarettes per day in the first 3 months of the trial or those who could not stop using any tobacco products during the trial; 13. Alcoholics or frequent drinkers in the 6 months preceding the trial, i.e. drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) or those who cannot stop using any alcoholic product during the trial; 14. Drug abusers or those who have used soft drugs (such as marijuana) in the 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) in the 1 year before the test; 15. Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm) or the abnormality of physical examination, electrocardiogram and laboratory examination has clinical significance (subject to the judgment of the clinical research doctor); 16. Subjects with rare hereditary galactose intolerance, lactose deficiency or glucose-galactose malabsorption; 17. Those who received inactivated vaccine within 1 month before screening, received live/attenuated vaccine within 3 months before screening or planned to receive inactivated/live/attenuated vaccine during the trial; 18. Subjects may not be able to complete the study due to other reasons or the researchers believe that they should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs;Physical examination;Laboratory examination;ECG examination; | — |
Countries
China
Contacts
Public ContactYang Guoping/ Huang Jie
Outcome results
None listed