PCa(prostatic cancer)
Conditions
Interventions
Four doses groups:75,150,300,450 mg of experimental drugs were given in turn
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) aged 18-45 (including boundary value), male; (2) the body weight of male subjects >=50kg, and the body mass index (BMI) is within the range of 19.0~26.0 kg/m2 (BMI = body weight (kg)/height 2 (m2)), including the boundary value; (3) the subjects did not have unprotected sex within 2 weeks before the screening, and they did not have a birth or sperm donation plan during the test period and within 3 months after the end of the test, and they voluntarily took effective physical contraception measures; (4) before the test, have a detailed understanding of the nature, significance, possible benefits, possible inconvenience and potential risks of the test.Able to understand the procedures and methods of this study, willing to complete this study in strict accordance with the clinical trial protocol, and willing to sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) those who are known to be allergic to the drugs or excipients in this study, or who have a specific allergy history (allergic asthma, urticaria, eczema, etc.), or who have allergic constitution (such as allergic to two or more drugs, food or pollen); (2) those who have or are currently suffering from any serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities or any other diseases that can interfere with the test results; (3) patients who had undergone major surgery within 4 weeks prior to the trial or who planned to undergo surgery during the study period; (4) those who had taken any medicine (including vitamins and Chinese herbs) within 14 days before the trial; (5) any drugs that inhibit or induce liver drug metabolism (e.g., inducers -- barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) were used within 30 days prior to the trial;Inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, clarithromycin, nefamazolidone, ritonavir and azanavir; (6) those who have taken any drug or participated in any drug clinical trial within 3 months prior to the trial; (7) blood donation or massive blood loss (>=200mL) within 3 months before the test, receiving blood transfusion or using blood products; (8) those who have special requirements on diet and cannot follow the unified diet; (9) do not avoid eating any special food (including tobacco, alcohol, caffeine, etc.) related to the study within 48 hours before the first use of the study drug and during the study period; (10) people who consumed excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =200 mL) every day for 3 months before the study; (11) smokers or those who smoked more than 5 cigarettes per day in the 3 months before the study; (12) heavy drinkers or frequent drinkers in the 6 months prior to the trial, i.e., those who consumed more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) or who exhaled alcohol positively; (13) drug abusers or users who used soft drugs (e.g., marijuana) 3 months before the trial or hard drugs (e.g., cocaine, phenyclohexidine, etc.) 1 year before the trial; (14) patients with abnormal vital signs (systolic pressure <90 mmHg or & gt;140 mmHg, diastolic blood pressure <50 mmHg or & gt;90 mmHg.Heart rate & lt;50 BPM or & gt;100 BPM) or physical examination, ecg, laboratory examination and other abnormalities have clinical significance (as determined by the clinician); (15) those with positive results of one or more of the tests for hepatitis b surface antigen, hepatitis c virus antibody, anti-human immunodeficiency virus antibody or anti-syphilis serotonin; (16) other reasons were considered inappropriate by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;plasma concentration; | — |
Contacts
Public ContactGuoping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Outcome results
None listed