None listed
Conditions
Interventions
Fasting:1 tabalet of IP taken per period, total 4 periods
Fed:1 tabalet of IP taken per period, total 4 periods
Sponsors
Phase I Centre, The First Hospital of Jilin University
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Prior to the signing of informed consent, and fully understand the study content, process and possible adverse event 2) Able to complete the study according to the study plan; 3) Male, aged from 18 to 65 years (including the age of 18 years and years old); 4) The weight was not less than 50 kg. Body mass index (BMI) = body weight (kg) / height2 (M2), BMI between 18 and 28 (including the critical value); 5) Participants are willing to have no pregnancy plan within the next 6 months and take effective contraceptive measures voluntarily; 6) Health: non history for abnormal heart, liver and kidney, gastrointestinal, nervous system, and mental disorders and metabolic abnormalities, physical examination shows there is normal or abnormal without clinical significance for blood pressure, heart rate, ECG, respiratory system, liver and kidney function and blood tests.
Exclusion criteria
Exclusion criteria: 1) From 1 to 3 months prior to the first drug administration, daily smoking more than 3 cigarettes, or before the first administration within 1 months smoking or using any type of tobacco products, including any kind of contain nicotine cessation products such as nicotine lozenge, nicotine gum; 2) Allergic to abiraterone tablets or its accessories; 3) Blood donation or massive blood loss (450 mL) within 3 months before first administration; 4) Taking any alcoholic products within 24 hours before drug administration; 5) Alcohol and narcotic drugs screening positive or drug abuse history in the past 5 years or the use of narcotic drugs within 3 months before the study; 6) Asthma or seizures history; 7) Any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis, gastric and duodenal ulcers, etc.; 8) The history of gastrointestinal disorders with dysphagia or any effect of drug absorption; 9) With injure diseases of ocular surface (such as corneal perforation and ulcers, etc.); 10) Take any drugs that alter the activity of the liver enzyme within 28 days before taking the study drugs; 11) Take any prescription drugs, non-prescription drugs, any vitamin products or herbs within 14 days before taking the study drugs; 12) Take a special diet (including pitaya, mango, grapefruit, and / or xanthine diet etc.) or have strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors within 2 weeks before taking the study drugs; 13) Use any drug that can change in gastrointestinal tract environment (especially the increase of the pH value of the gastrointestinal tract, such as proton pump inhibitors of tenatoprazole, omeprazole, lansoprazole and esomeprazole; H2 antagonist Rene Titi, cimetidine, famotidine and antacids; sodium bicarbonate, Magnesium Oxide three, aluminum hydroxide, magnesium silicate; gastric mucosal protection as sucralfate etc.); 14 Change in diet or exercise habits recently; 15) Take the study drug, or participating in a clinical trial within 3 months before the study; 16) Take chocolate, any caffeine containing food or drink within 48 hours before taking the study drug; 17) ECG is abnormal and with clinical significance; 18) clinical laboratory test is abnormal and with clinical significance, or other clinical findings with clinical significance for following disease (including but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular disease); 19) Hepatitis (including hepatitis B and hepatitis C) and HIV is positive in the screening; 20) The serum electrolytes, cortisol, testosterone and aldosterone were abnormal and with clinically significant; 21) Creatinine clearance rate was <80ml/min during screening; 22) With acute disease occurring before the screening or before the study drugs taking; 23) other subjects who is inappropriate to join in the study under the investigator judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Parameters; | — |
Countries
China
Contacts
Public ContactYanhua Ding
Phase I Centre, The First Hospital of Jilin University
Outcome results
None listed