None listed
Conditions
Interventions
Group A:FCN437c 100mg was taken orally on an empty stomach for Day1, 200mg itraconazole was taken orally after meals for Day13 to Day16 and Day18 to Day24, and FCN437c 100mg and 200mg itraconazole wer
Group B:FCN437c 200mg was taken orally on an empty stomach for Day1, 600mg of Rifampicin was taken orally on an empty stomach for Day13 to Day19 and Day21 to Day27, and FCN437c 200mg and 600mg of Rifa
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Sign informed consent before the trial and fully understand the trial's contents, process, and possible adverse reactions; Voluntarily participate and be able to complete the study in accordance with the requirements of the trial protocol; 2. Healthy adult subjects aged 18 to 45 years; 3. Weight >=50kg for males, and >=45kg for females, BMI 19-24 kg/m^2; 4. No clinical significance in physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal ultrasound, and chest X-ray examination; 5. Subjects and their female partners have no reproductive plan, no sperm donation or egg donation plan, and adopt voluntary and effective contraceptive measures, from 2 weeks before screening to 6 months after the last administration of medication, and ensure that one or more non-drug sexual contraceptive measures are used in sexual life from 2 weeks before screening to 1 month after the last administration of medication.
Exclusion criteria
Exclusion criteria: 1. Diseases with abnormal clinical manifestations that need to be excluded have occurred or are occurring before screening, including but not limited to diseases of the nervous/mental system, respiratory system, cardiovascular and cerebrovascular system, digestive system, blood and lymphatic system, urinary system, endocrine system and immune system; 2. Have or have a history of any other disease or medical condition that can interfere with the results of the test; 3. Patients with acute disease during the screening period or before the study drug use; 4. Patients who had surgery 3 months before screening or planned to have surgery during the trial; 5. Positive for any one of the test results of human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C virus antibody or treponema pallidum antibody; 6. Clear allergy to CDK4/6 or its preparation ingredients; Have drug allergy or allergic constitution; 7. Used any prescription drugs, Chinese herbs and/or non-prescription drugs and health products within 4 weeks before administration; 8. Those who were vaccinated within 1 month prior to screening, or who plan to be vaccinated during the trial; 9. Patients with a history of drug abuse or addiction; 10. Those who have donated blood or plasma within 1 month prior to screening, donated more than 400 mL of blood within 3 months, or received blood transfusions or used blood products within 3 months; 11. Enrolling in any clinical trial within 3 months prior to screening, or planning to participate in other clinical trials during the trial period; 12. Patients with a history of fainting needle and fainting blood, patients who cannot tolerate venous puncture blood collection and patients with difficulty in blood collection; 13. Smokers who smoked more than 5 cigarettes a day in the 3 months prior to screening, or who could not stop using any tobacco products during the test period; 14. Alcohol abusers or those who drank regularly in the 3 months prior to screening, i.e. drank more than 14 standard units per week (1 unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) or who could not stop drinking alcohol or any alcoholic products during the test period; 15. Those who consumed excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups a day, 1 cup =200 mL) in the 3 months prior to screening, or who could not stop consuming any beverages containing caffeine (such as coffee, chocolate, tea, cola, etc.) during the trial period; 16. Special diets (including dragon fruit, mango, grapefruit, etc.) and/or xanthine diets (anchovies, sardines, beef liver, kidney, etc.) were administered during the trial; Use food or drugs that have an effect on liver drug enzymes; 17. Other circumstances that the researcher considers unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration;Time to peak plasma concentration;Area under the blood concentration-time curve from zero to the last quantifiable concentration;The area under the concentration curve from zero to inferred infinity;Adverse events;Vital signs;Laboratory examination;Routine 12-leads electrocardiogram;Physical examination; | — |
Countries
China
Contacts
Public ContactHu Wei
The Second Hospital of Anhui Medical University
Outcome results
None listed