Growth disorders
Conditions
Interventions
Trial-Reference Group:The first cycle of administration: test preparation (T)
the second cycle of administration: reference preparation (R)
Refence-Trial Group:The first cycle of administration: test preparation (R)
the second cycle of administration: reference preparation (T)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in clinical trials and sign informed consent; 2. 18-45 years old (including cut-off value) healthy adult volunteers, both male and female; 3. Pass the required physical examination within 15 days before the test, the body mass index (BMI) is within the range of 19~24 kg/m2, and the weight is within the range of 45~75 kg (including the cut-off value); 4. Subjects agree and take reliable contraceptive measures to ensure that there is no birth plan within 3 months after the start of the study; 5. The subject can communicate well with the researcher and can complete the research in accordance with the research regulations.
Exclusion criteria
Exclusion criteria: 1. Upon questioning, the subject has an obvious history of drug or food allergies; 2. After being asked, the subject has received over-the-counter drugs and/or prescription drugs, vitamins and/or traditional Chinese medicine treatments within 2 weeks; 3. Subjects were asked to have long-term use of certain drugs or a history of drug abuse, smoking (average 10 cigarettes/day or more) or alcohol abuse (alcohol 30 mL/day or more); 4. Subjects confirmed to be infected with any one of hepatitis B surface antigen, hepatitis C, HIV and syphilis tests; 5. Subjects were asked to have the following medical history: diabetes or elevated fasting blood glucose during screening, any clinically significant cardiac, respiratory (except mild asthma), kidney, liver, gastrointestinal, blood or mental illness, or Disorders, or any uncontrolled medical diseases; hemorrhoids or anal diseases with frequent blood in the stool; 6. Subjects who have been asked to participate in clinical trials and receive trial intervention treatment within 3 months before receiving the study drug; 7. Subjects who have suffered major illnesses or severe symptoms or have undergone surgery during the 3 months before the study; 8. After inquiry or inspection, it is found that the subject has a history of autoimmune diseases, such as psoriasis, rheumatoid arthritis, inflammatory bowel disease, etc.; history of malignant tumor diseases; history of mental illness; 9. Those who have active infection in need of treatment upon questioning; 10. Subjects who have been asked to donate blood or receive blood transfusion or hemorrhage (greater than 400 mL) within 3 months before receiving the study drug; 11. Pregnant or lactating women; or women of childbearing age who have a positive blood HCG test before administration; have recently had a childbirth plan and refuse to take effective physical contraceptive measures within 3 months after the start of the study (including but not limited to contraception) Sets, etc.); 12. Disagree with the prohibition of special diets (including chocolate, coffee and caffeinated foods, tea, dragon fruit, mango, grapefruit and/or xanthine diets, etc.) within 48 hours before enrollment; 13. Disagree to stop strenuous exercise during the test, or disagree to obey the relevant arrangements of the test; 14. Those who have received live vaccines or inactivated vaccines within 3 months before screening; 15. Those who have special requirements for diet and cannot follow a unified diet; 16. The researcher believes that the subject is not suitable for participating in this trial for any reason; 17. Researchers or research assistants, pharmacists and other staff participating in this study; 18. Circumstances where the abnormality is judged by the clinician to be of clinical significance, including physical examination, vital sign examination, electrocardiogram or clinical laboratory examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum blood concentration;Area under blood concentration-time curve0-t;Area under blood concentration-time curve0-8; | — |
Countries
China
Contacts
Public ContactZheng Li
Outcome results
None listed