Breast cancer
Conditions
Interventions
Fasting group 2:The reference preparation was taken on an empty stomach in the first cycle
the test preparation was taken on an empty stomach in the second cycle.
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Be able to give signed Informed Consent Form before study, and fully understand the study content, process and possible adverse reactions; 2. Able to complete the study in compliance with the protocol; 3. Subjects (including their partner) agree to adopt effective contraceptive measurements and not plan a pregnancy from 2 weeks before dosing to 6 months after the last dosing of study drug; 4. Healthy males and females between 18 and 50 years of age, inclusive; 5. At least 50.0 kg for male subjects, 45.0 kg for female subjects, with a Body Mass Index (BMI) between 18-28 kg/m2, inclusive (BMI = weight/height2); 6. Physical examination and vital signs are normal or abnormal but without clinical significance.
Exclusion criteria
Exclusion criteria: 1) More than 5 cigarettes per day within 3 months prior to the study; 2) A history of allergy to study drug or allergic to multiple drugs and food; 3) A history of drug or alcohol abuse(at least 14 units of alcohol per week: 1 unit = 285 mL beer or 25 mL liquor, or 100 mL wine); 4) Donation or loss of a significant volume of blood (> 450 mL) within three months prior to screening; 5) History of difficulties in swallowing, or any gastrointestinal disease which could affect drug absorption; 6) Suffering from any diseases that increase the risk of bleeding, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers, etc.; 7) Use of any medication known to alter hepatic enzyme activity within 28 days prior to screening; 8) Use of any prescription drugs, over-the-counter (OTC) drugs, vitamin products or herbal medicine within 14 days prior to screening; 9) Consumption of any special food or beverage (e.g., grapefruit) or subjects have exercised strenuously or have any other factors affecting drug absorption, distribution, metabolism and excretion within 2 weeks prior to screening; 10) Use of following drugs before 7 days prior to screening: known strong CYP3A4 inhibitors (amprenavir, atazanavir, boceprevir, clarithromycin, conivaptan, delavirdine, diltiazem, erythromycin, fosamprenavir, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, miconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, verapamil, voriconazole), known strong CYP3A4 inducers (Carbamazepine, felbamate, nevirapine, phenobarbital, phenytoin, primidone, rifabutin, rifampicin, rifapentine and St. John's wort), known drugs prolonged QT interval. 11) Significant changes in diet or exercise habits recently; 12) Participation in other drug clinical study or use of any study drug within 3 months prior to receiving study drug; 13) Any clinically significant abnormalities in 12-lead electrocardiogram; 14) A positive pregnancy test or subject is lactating during screening or study period if the subject is female; 15) Any clinically significant abnormalities in laboratory tests or other clinically significant diseases found within 6 months (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular disease); 16) A positive test result for viral hepatitis (including Hepatitis B and C), HIV antibody and treponema pallidum antibody; 17) Any acute diseases or use of medication during screening to prior to receiving study drug; 18) Consumption of chocolate or any food or beverage containing caffeine or rich containing xanthine within 48 h prior to receiving study drug; 19) Consumption of any product containing alcohol within 48 h prior to receiving study drug; 20) A positive result for drug abuse test; 21) The subjects whom investigator consider them to be unfit for the study due to other factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactYanhua Ding
The First Hospital of Jilin University
Outcome results
None listed