breast cancer
Conditions
Interventions
1:Recombinant anti-HER2 humanized monoclonal antibody for injection Usage and dosage: freeze-dried powder for injection
2:Chinese generic name: Trastuzumab for injection (Herceptin, Herceptin) Usage and dosage: freeze-dried powder for injection (including diluent)
Sponsors
Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male, aged 18-45 years; 2. Body weight >= 50kg, body mass index (BMI) between 19~25kg/m2 (including boundary value); 3. Based on the results of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory examination, the investigator believes that the subjects are in good health, with a history of centerless, liver, kidney, digestive tract, nervous system, mental and metabolic abnormalities;Body temperature, blood pressure, heart rate, respiratory status and laboratory tests are all normal or abnormal (at the discretion of the clinician); 4. Left ventricular ejection fraction (LVEF) > 60%; 5. Subjects must give informed consent to the study prior to the study and voluntarily sign written informed consent; 6. Subjects will be able to communicate well with the investigator and complete the study according to the study regulations.
Exclusion criteria
Exclusion criteria: 1. Patients who had received surgical operation within 4 weeks before the experiment; 2. Allergic to this product or any other excipients; A person with a history of any serious clinical disease, such as circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, metabolic abnormalities, or any other disease or physiological condition that can interfere with the test results; Receiving treatment for gastrointestinal problems, cramps, gastrointestinal ulcers, urinary tract infarction, mechanical ileus, ureterospasm, biliary tract diseases, depressive disorders or liver diseases; 5. Gastrointestinal and liver and kidney diseases that can affect drug absorption or metabolism; 6. Severe bleeding factors that are known to affect venous blood collection; 7. Patients with a history of malignant tumor; Any drug that inhibits or induces hepatic metabolism (e.g., inducers -- barbiturates, carbazepine, phenytoin, glucocorticoids, omeprazole) was administered 30 days before the trial.SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines); 9. Abnormal ecg (of clinical significance) or abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg;Heart rate 100 BPM); 10. Positive for HIV, hepatitis B surface antigen, hepatitis C or treponema Pallidum antibody; 11. Alcoholics or frequent drinkers in the 6 months prior to the trial, i.e., drinking more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits of 40% alcohol or 150 mL wine); 12. Smokers or those who smoked more than 5 cigarettes per day in the 3 months before the study; 13. Drug abusers or users of soft drugs (e.g., marijuana) in the 3 months prior to the trial or hard drugs (e.g., cocaine, phenylhexidine, etc.) in the 1 year prior to the trial; 14. Any food allergies or special requirements on diet, and cannot comply with the unified diet; 15. Drinking excessive amount of tea, coffee and/or caffeinated beverages (8 cups or more, 1 cup =250ml) per day; 16. Had taken any drug within 14 days before the trial; 17. Those who took any clinical trial drug or participated in any clinical trial drug within 3 months prior to the trial; 18. Donate blood 3 months before the trial or be sampled as subjects; 19 Subjects who may be unable to complete the study for other reasons or who the investigator considers should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration; | — |
Countries
China
Contacts
Public ContactYangGuoping
Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed