None listed
Conditions
Interventions
Sponsors
Hebei General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: 1) The subjects fully understand the purpose, nature, method and possible adverse reactions of the trial, voluntarily participate in the trial, and sign the informed consent form before the start of the trial; 2) healthy male and female subjects over the age of 18 years inclusive; 3) Male weight= 50.0 kg, female weight= 45.0 kg; Body mass index (BMI) in the range of 19.0~26.0 kg/m2 (including critical value); 4) Subjects (including male subjects) willing to have no pregnancy plan and voluntarily take effective contraceptive measures and no sperm or egg donation plan from the date of screening to 6 months after the last administration of the study drug; 5) The subjects can communicate well with the investigator and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1) Those with allergies, or a history of food or drug allergies; 2) History of dysphagia or any gastrointestinal disease that affects the absorption of the drug; 3) Have a history of chronic disease or serious disease (consultation); 4) Those who have undergone surgery within 3 months prior to screening, or plan to undergo surgery during the study, or have previously undergone surgery that will affect drug absorption, distribution, metabolism, and excretion; 5) Those who cannot tolerate venipuncture, and those who have a history of needle sickness and blood; 6) Use of any drug that inhibits or induces liver metabolism of the drug within 28 days prior to screening; 7) Vital sign examination, physical examination, laboratory examination and test-related examination, detection of abnormalities and clinical significance judged by the researcher; 8) One or more positive tests for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody or treponema pallidum antibody test; 9) Female subjects are breastfeeding or pregnancy test results positive during the screening period or during the trial; 10) Those with a history of drug abuse or positive drug screening within 6 months prior to screening; 11) Those who used any prescription drugs, Chinese herbal medicines, over-the-counter drugs and vitamins within 2 weeks before screening; 12) Screening for blood donation or large blood loss (> 400mL), blood transfusion or blood product use within 3 months before screening, or planning to donate blood during the study; 13) Those who smoked more than 5 cigarettes per day within 3 months before screening, or could not stop using any tobacco products during the trial period; 14) Those who drank more than 14 units per week within 3 months before screening, or could not abstain from alcohol during the trial period; 15) Those who consumed excessive amounts of tea, coffee and/or caffeinated beverages per day within 3 months prior to screening; 16) Those who have consumed dragon fruit, mango, grapefruit, lime, star fruit or food or beverages prepared by them within 7 days before screening; 17) Those who have participated in other drug clinical trials within 3 months before screening or those who have not participated in clinical trials themselves; 18) Those who have special dietary requirements and cannot accept a unified diet; 19) Subjects judged by other investigators to be unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2; | — |
Countries
China
Contacts
Public ContactMa Jie
Hebei General Hospital
Outcome results
None listed