Bioavailability study in healthy subject
Conditions
Interventions
Fasting Group A (TRR):In stage 1, take 1 tablet of the test preparation on an empty stomach, in stage 2, take 1 tablet of the reference preparation, and in stage 3, take 1 tablet of the reference pr
Fasting Group B (RTR): in stage 1, take 1 tablet of the reference preparationon an empty stomach, In stage 2, take 1 tablet of the test preparation , and in stage 3, take 1 tablet of the reference pr
Fasting Group C (RRT): in stage 1, take 1 tablet of the reference preparation on an empty stomach, in stage 2, take 1 tablet of the reference preparation, and In stage 3, take 1 tablet of the test pr
Feding Group A (TRR):In stage 1, take 1 tablet of the test preparation after meals, in stage 2, take 1 tablet of the reference preparation, and in stage 3, take 1 tablet of the reference preparation
Feding Group B (RTR): in stage 1, take 1 tablet of the reference preparationon after meals, In stage 2, take 1 tablet of the test preparation , and in stage 3, take 1 tablet of the reference preparat
Feding Group C (RRT): in stage 1, take 1 tablet of the reference preparation after meals, in stage 2, take 1 tablet of the reference preparation, and In stage 3, take 1 tablet of the test preparation
Sponsors
Hebei General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Subjects must give informed consent to this study before screening, and voluntarily sign a written informed consent; (2) Healthy subjects over 18 years of age (including 18 years of age), with an appropriate ratio of male to female; (3) The body weight of male subjects is =50.0kg, the body weight of female subjects is =45.0kg, and the body mass index (BMI) is in the range of 19.0 ~ 26.0kg/m2 (including boundary values); (4) The subject or his or her partner has no fertility plan (including sperm and egg donation plan) for one month before the trial and three months after the trial ends and voluntarily takes non-drug contraceptive measures; (5) The subject's blood pressure should meet the following criteria: systolic blood pressure =90mmHg and <140mmHg, diastolic blood pressure =60mmHg and <90mmHg.
Exclusion criteria
Exclusion criteria: (1) Those who have had or currently have serious or chronic diseases that are not suitable for participation in this study, including cardiovascular, digestive, respiratory, urogenital, hematological and lymphatic, endocrine, immune, psychiatric, neurological, skin, and musculoskeletal diseases (inquiries); (2) Allergic constitution, drug, food and other allergies have allergic history; (3) The subject is unable to communicate well with the researcher and is unwilling to comply with the requirements of the study; (4) A history of disease that affects the course of the drug in vivo (such as chronic diarrhea, inflammatory bowel disease, gastroesophageal reflux disease, abnormal liver function, or gastric or intestinal surgery); Or severe vomiting and diarrhea within a week before screening; (5) Those who had undergone surgery within 3 months prior to screening or planned to undergo surgery during the study period; (6) Have taken any drugs (including any prescription drugs, over-the-counter drugs, Chinese herbs, vitamins) and health products within 28 days before screening; (7) Those who participated in any drug clinical trial and used any experimental drug within 3 months before screening; (8) People who have lost blood or donated blood (including blood components) =200mL within 90 days prior to screening (except for female menstrual period), or who intend to donate blood (including blood components) during or within 90 days after the end of the trial; (9) Have special dietary requirements, can not comply with the uniform diet, or can not tolerate high-fat diet, or lactose intolerance; (10) Excessive consumption of tea, coffee and/or caffeinated beverages (more than 2000mL) per day; Or consumed any caffeine-rich beverage or food, such as coffee, tea, cola, chocolate, or grapefruit or food/drink containing grapefruit during the 14 days prior to screening until the end of the trial; (11) Smoking =3 pieces per day; Or who smoked or used any type of tobacco product during the trial, including any smoking cessation product containing nicotine; (12) alcoholism (drinking more than 14 standard units per week, with 1 standard unit containing 14g of alcohol, such as 360mL beer or 45mL spirits with 40% alcohol or 150mL wine); Or any alcohol-containing products taken during the trial; Or pre-check-in alcohol breath test >0.0mg/100mL per cycle; (13) Those who have a history of drug dependence/abuse or a positive drug test in the past 1 year; (14) Hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody test results are positive; (15) Pregnant and lactating women; (16) Female subjects had unprotected sex within 2 weeks prior to screening; (17) Patients who have a history of needle fainting or blood fainting, or can not tolerate intravenous blood collection or swallowing difficulty; (18) Patients with abnormal vital signs, electrocardiogram, chest film or laboratory examination and judged by the investigator to be clinically significant; (19) Patients with postural hypotension [after lying on their back for 5 minutes, the systolic blood pressure decreased > 20mmHg or the diastolic blood pressure decreased > 10 MMHG for 1 to 3 minutes after standing up (or the systolic blood pressure decreased > 10 MMHG, and dizziness or fainting occurred); (20) Subjects deemed unsuitable for participation by other investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;?z;t1/2;AUC_%Extrap; | — |
Countries
China
Contacts
Public ContactMA Jie
Hebei General Hospital
Outcome results
None listed