CRPC
Conditions
Interventions
1:Phase I fasting oral Abiraterone Acetate
Phase II oral reference Zytiga
Phase III oral oral reference Zytiga
2:Phase I oral reference Zytiga
Phase II fasting oral Abiraterone Acetate
3:Phase I oral reference Zytiga
Phase II oral oral reference Zytiga
Sponsors
The first hospital of jilin university
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male subjects between 18 and 45 years of age, at least 50kg; 2. Body Mass Index (BMI) between 18-26kg/m2, inclusive(BMI = kg/m2); 3. Health: not intentional, liver, kidney, gastrointestinal tract, nervous system, mental disorder and metabolic abnormalities, such as history, physical examination showed the blood pressure, heart rate, ecg, respiratory system, liver, kidney, and normal or abnormal urinalysis performed without clinical significance; 4. The PT and aPTT is in the normal value; 5. creatinine clearance rate is more than 50mL/min; 6. Male subject should agree to use condom correctly and constantly, and ask his female partner to use one of the methods mentioned till the end of study; 7. To be able to understand and provide written informed consent and voluntary consent to participate in the study; 8. To be able to complete the study in compliance with the protocol.
Exclusion criteria
Exclusion criteria: 1. A clinically significant laboratory abnormality or other clinical findings indicative of a clinically significant exclusionary disease (including but not limited to renal, hepatic, gastrointestinal, cardiovascular, neuropsychic disease); 2. A history of hypersensitivity to tenofovir or any other component of Abiraterone Acetate Tablets; 3. History of renal or liver disease; 4. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption; 5. Positive test result of HIV antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody; 6. Positive alcohol breath test; 7. Positive pregnancy test or female who is lactating; 8. A recent history of alcoholism ( 450 mL) within 56 days prior to the initial dose of study medication; 16. Use of any prescription drugs, herbal supplements within 14 days prior to receiving study drug; 17. Consumption of any beverages or food with abundant xanthine and any grapefruit or grapefruit-containing juices within 72 hours prior to receiving study drug; 18. Use of any over-the-counter (OTC) drugs other than vitamins within 48 hours prior to receiving study drug; 19. Consumption of any caffeine-containing foods or beverages within 48 hours prior to receiving study drug; 20. Consumption of alcohol within 48 hours prior to receive study drug; 21. Any condition which in the opinion of Investigator would interfere with the participants ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he or she took part in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration of Tenofovir Disoproxil Fumarate Tablets ;safety indicator; | — |
Countries
China
Contacts
Public ContactDing Yanhua
The First Hospital of Jilin University
Outcome results
None listed