A Drug-drug Interaction Study of Famitinib Malate With a Proton Pump Inhibitor in Healthy Adult Subjects

Inclusion criteria

• Participants should sign the informed consent before the study, and fully understand the content, process and possible adverse reactions of the study;
• Capable to complete the study according to the requirements of study protocol;
• Healthy male and female subjects aged between 18 and 45 (inclusive) at the time of signing the informed consent, of which no less than 1/3 are female subjects;
• Participants should have no fertility plan from signing the informed consent until 6 months after the last medication, take effective contraceptive measures voluntarily and have no sperm donation plan. The serum HCG test of fertile women must be negative before Screening;
• Body weight ≥ 50.0 kg for men and body weight ≥ 45.0 kg for women, and body mass index (BMI) within the range of 19.0 to 28.0 kg /m2 (inclusive);
• Creatinine clearance (CLCr) ≥80 mL/min, and creatinine is less than or equal to the upper limit of normal value.

Exclusion criteria

• Those who donated blood or suffered blood loss ≥400 mL within 3 months prior to Screening, donated blood or suffered blood loss ≥200 mL within 1 month prior to Screening, or received blood transfusion;
• Allergic constitution, including a history of severe drug/food allergy; Any history of allergy to famitinib malate capsules or omeprazole magnesium enteric-coated tablets;
• Any history of drug abuse, positive results for alcohol, nicotine or drugs at Screening;
• Those who have heavy smokers and alcoholic will not be able to prohibit smoking and alcohol during the trial;
• Any history of dysphagia or any gastrointestinal disease that affects drug absorption;
• Those who have any uncontrolled peptic ulcer, colitis, pancreatitis, etc.;
• Those who have received any operation within 6 months before Screening; Previous surgery affecting gastrointestinal absorption (including gastrectomy, intestinal resection, gastric contraction surgery, etc.);
• Subjects with any clinically significant acute disease occurring within 1 month prior to Screening;
• QTcF>470 msec for women or >450 msec for men;
• Any pre-existing chronic or severe medical history of nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism, and musculoskeletal system;
• Participation in any clinical trial within 3 months before Screening;
• Those who took any other drugs that affect liver metabolism within 28 days prior to taking the investigational drug;
• Those who took any prescription or non-prescription drugs, any vitamin products or herbal medicine within 14 days prior to receiving the investigational drug;
• Abnormal vital signs at Screening;
• Clinical laboratory tests, infectious disease screening, 12-lead electrocardiogram, abdominal B ultrasound, X-ray or CT examination with abnormalities and clinical significance;
• Consumption of grapefruit or grapefruit products, caffeine, or xanthine foods or beverages within 48 hours prior to taking the investigational drug; Strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.;
• Lactating women;
• History of injection needle or blood fainting, those who have difficulty in blood collection or cannot tolerate venepuncture blood collection; Those who cannot accept a uniform diet;
• Subjects with other factors unsuitable to participate in the study considered by the researcher or subjects withdraw from the study due to their own reasons.