prostatic cancer
Conditions
Interventions
Group A:Take self-developed abiraterone acetate soft capsules 50mg orally in fasting ,wash out >=7days, then take 1000mg abiraterone acetate tablets, Zytiga orally in fasting state
Group AC:After meals, 50mg self-developed abiraterone acetate soft capsules were taken orally once, wash out >=7days, then take 1000mg abiraterone acetate tablets, Zytiga orally in fasting state
Group BK:Take self-developed abiraterone acetate soft capsules 100mg orally in fasting ,wash out >=7days, then take 1000mg abiraterone acetate tablets, Zytiga orally in fasting state
Group BC:Take self-developed abiraterone acetate soft capsules 100mg orally in fed, wash out >=7days, then take 1000mg abiraterone acetate tablets, Zytiga orally in fasting state
Group CK:Take self-developed abiraterone acetate soft capsules 150mg orally in fasting, wash out >=7days, then take 1000mg abiraterone acetate tablets, Zytiga orally in fasting state
Group CC:Take self-developed abiraterone acetate soft capsules 150mg orally in fed ,wash out >=7days, then take 1000mg abiraterone acetate tablets, Zytiga orally in fasting state
Group DK:Take self-developed abiraterone acetate soft capsules 200mg orally in fasting ,wash out >=7days, then take 1000mg abiraterone acetate tablets, Zytiga orally in fasting state
Group DC:Take self-developed abiraterone acetate soft capsules 200mg orally in fed ,wash out >=7days, then take 1000mg abiraterone acetate tablets, Zytiga orally in fasting state
Sponsors
Hangzhou First People's Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Fully understand the purpose, nature, method and possible adverse reactions of the test, volunteer as a subject, and sign informed consent prior to the start of any study procedure; 2. Male aged above 18 years (including 18 years old); 3. Weight >=50.0 kg; Body mass index [BMI= weight (kg)/ height (m)^2] in the range of 19.0-26.0 kg/m^2, including the critical value; 4. No fertility plan or sperm donation plan within 6 months from the first drug administration to the last drug administration, and take effective contraceptive measures voluntarily; 5. Be able to communicate well with the investigators, comply with the requirements of the whole study, and be willing to stay in the clinical trial ward as required.
Exclusion criteria
Exclusion criteria: 1. Diseases that occur or are occurring prior to screening with clinical abnormalities requiring exclusion, including but not limited to the nervous/psychiatric system, respiratory system, cardiovascular system, digestive system (history of dysphagia or any gastrointestinal disease affecting drug absorption), blood and lymphatic system, liver and kidney function, endocrine system, immune system, metabolism, bone and other systems of chronic disease or serious disease history, as determined by the investigator clinical significance or impact on the study results; 2. Patients with psychoneurotic diseases (such as epilepsy, convulsion, delirium, etc.) that have occurred or are occurring before screening and need to be excluded with abnormal clinical manifestations; 3. Patients who had a history of hospitalization or surgery within 3 months prior to screening, or who planned to have surgery during the study period, or who had surgery that would affect the pharmacokinetic behavior of drugs in vivo (e.g., partial resection of liver, kidney, gastrointestinal tract); 4. Allergic history to abiraterone or any drug component or similar drugs; Or have a history of allergy to pollen or other specific allergies (asthma, allergic rhinitis, eczema); 5. The average weekly alcohol consumption in the 6 months before screening is not less than 14 units (1 unit of alcohol ˜285mL beer or 25mL liquor with 40% alcohol content or 100mL wine), or during the test period (screening day to the second stage of discharge) do not agree or cannot stop using any alcohol products; 6. The average daily smoking amount in the 6 months before screening is not less than 5 pieces, or during the test period (screening day to the second stage of discharge) do not agree or cannot stop using any tobacco products; 7. Any drug that inhibits/induces liver metabolism of the drug (such as: inducers - barbiturates, carbamazepine, phenytoin sodium, glucocorticoids, omeprazole;Inhibitors --SSRI antidepressants, Cimetidine, diltiazem, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines), or any drug that alters the gastrointestinal environment (such as proton pump inhibitors tytoprazole, omeprazole, lansoprazole, esoprazole, etc.; H2 antagonists ranitidine, cimetidine, famotidine, etc.; Antacids sodium bicarbonate, magnesium oxide, aluminum hydroxide, magnesium trisilicate, etc. Gastric mucosal protective agents such as sulfoaluminum, etc.) , or any other drug that has drug interaction with the product within 30 days prior to screening; 8. Patients who have consumed any prescription drugs, non-prescription drugs, vitamins, health products, Chinese herbs, Chinese patent medicines or drinks containing Chinese medicine in the 14 days before screening; 9. Those who have been vaccinated within 30 days prior to screening or plan to be vaccinated during the trial; 10. Patients who have donated blood or suffered significant blood loss (>=200mL) within 3 months prior to screening, or who have received blood transfusions or used blood products, or who plan to donate blood within 1 month after the end of the trial; 11. Vital signs examination, physical examination, laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function, endocrine examination), four tests of blood transfusion, 12-lead electrocardiogram examination, X-ray chest X-ray examination as judged by the investigator abnormal clinical significance; 12. Screeni
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;Vital signs;Laboratory examination;Twelve lead electrocardiogram;Physical examination;Adverse event; | — |
Countries
China
Contacts
Public ContactLin Nengming
Hangzhou First People's Hospital
Outcome results
None listed