Treatment of Advanced Prostate Cancer
Conditions
Interventions
Test Group:One tablet test product of Bicalutamide (50mg) as well as one tablet reference product of Casodex (containing Bicalutamide 50mg) will be administered to each subject in two administration p
Reference Group:One tablet reference product of Casodex (containing Bicalutamide 50mg) as well as one tablet test product of Bicalutamide (50mg) will be administered to each subject in two administrat
Sponsors
Aerospace Centre Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Chinese healthy adult male at the age of 18 to 40 years old (inclusive) and the same batch subjects age difference should not exceed 10 years old. (<=10 years old); 2. Having a Body Mass Index (BMI) between 19 and 24 (inclusive), calculated as weight in kg/(height in m2), and weight at least 50Kg; 3. Have no major disease, or have no clinical significance during screening, medical history, clinical examination, laboratory evaluations, 12- lead ECG and X-ray chest (postero-anterior view) recordings; 4. Be able to comply with the study procedures, in the opinion of the Principal Investigator; 5. Be able to give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution or known hypersensitivity or idiosyncratic reaction to bicalutamide or to test product and any component of reference product formula or to any drug; 2. Any serious disease or abnormal condition which might compromise the hemopoietic system, liver, kidney, endocrine, lung, central nervous, cardiovascular, immunity, skin, gastrointestinal tract or any other body system; 3. Ingestion of any drug at any time within 14 days before administration in Period I; 4. Patients who have taken drugs being harmful to main organs in the past 3 months prior to the trial; 5. Patients with any history of asthma; 6. People who weekly drink more than 28 units of alcohol (1 unit = 285 ml of beer or 25 ml of spirits or 1 glass of wine) or have drank within 48 hours prior to receiving the test product and during the study; 7. Daily smoking more than 5 or equivalent and can not quit smoking during the study period; 8. The presence of clinically significant laboratory abnormal values during screening; 9. Use of any recreational drugs or history of drug addiction or testing positive in screening period; 10. History of psychiatric disorders; 11. History of difficulty in donating blood; 12. Donation of blood or loss of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of test product.(Note: If loss of blood <=200 mL, the subject may be enrolled 60 days after blood donation); 13. A positive test result for hepatitis B surface antigen and anti-HCV antibodies; 14. A positive test result for HIV antibody and syphilis; 15. Receipt of any other investigational product or participation in any other clinical study within the period of 90 days prior to the first dose of study drug; 16. An unusual diet, for whatever reason (e.g. low-sodium), within 4 weeks prior to receiving the test product and throughout the subject's participation in the study; 17. During the screening, clinical liver enzyme (including ALT and AST) value is beyond the normal range.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bicalutamide concentration in plasma; | — |
Countries
China
Contacts
Public ContactYongming Lv
Aerospace Center Hospital
Outcome results
None listed