Healthy adults
Conditions
Interventions
Test group:Semaglutide injection, single dose, 0.5mg, administered subcutaneously in the abdomen
Control group:Ozempic, single dose, 0.5mg, administered subcutaneously in the abdomen
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign written informed consent; 2. Age 18-45 years old (including boundary values), male and female; 3. Male weight >=50kg, female weight >=45kg; Body mass index 19-26kg/m2 (including boundary values).
Exclusion criteria
Exclusion criteria: 1. history of blood system, cardiovascular system, kidney, liver, gastrointestinal tract, immune system, nervous system, spirit system and malignant disease with clinical significance, and any disease or physiological conditions that could be able to change the absorption, metabolism or elimination of drugs, or patients during the acute/chronic phase of various infections. Particular attention should be paid to previous or current cases of pancreatitis, gallstones, biliary tract infection, severe hyperlipidemia, thyroid nodules, thyroid C-cell tumor or family history of thyroid C-cell tumor, multiple endocrine adenomatosis type 2 or family history of endocrine adenomatosis; 2. Received human glucagon-like peptide-1 (GLP-1) drugs (e.g., liraglutide, exenatide, duracitide, lixisenatide, benallutide, losenatide, Semaglutide and other drugs of the same class) within 6 months before screening; 3. A history of diabetes, or impaired glucose tolerance, or glycosylated hemoglobin A1C (HbA1c) >=6.0%; 4. Patients with a definite history of injection site reaction, drug/food allergy, severe specific allergy, or allergy to study drug components and similar drugs (GLP-1) should not be included by the investigator; 5. The vital signs, physical examination, electrocardiogram, clinical laboratory and other examination results are abnormal and clinically significant as judged by the investigator; 6. Human immunodeficiency virus (HIV) - HIV P24 antigen/antibody, hepatitis c virus (HCV) antibody, syphilis specific antibody positive, anomalies of five makers of hepatitis B(hepatitis b surface antigen, hepatitis b surface antibody, hepatitis b e antigen and antibody of e of hepatitis b and hepatitis b core antibody) have clinical significance; 7. Skin abnormities, such as skin lesions, dermatitis, rashes, tattoos, etc. that affect the observation or evaluation of researchers at the site of administration(periumbilical area of the lower abdomen); 8. Those who have taken any drugs (prescription drugs, over-the-counter drugs, Chinese herbs, vaccines) or health products within 2 weeks before and during screening; 9. Smoke more than 5 cigarettes per day within 3 months before screening, or do not stop using any tobacco products during the test; 10. Those with abnormal alcohol breath test (greater than 0mg/100mL is abnormal) or excessive alcohol consumption; According to the Dietary Guidelines for Chinese Residents, male excessive drinkers are those who consume more than 25 grams (0.5 liang) of alcohol per day, which is equivalent to 750 ml (1 bottle) of beer, 250 ml (1 cup) of wine, 75 grams (1.5 liang) of 38° white liquor, or 50 grams (1 liang) of high level white liquor; Female excessive drinkers drink more than 15 grams of alcohol per day, equivalent to 450 ml of beer, 150 ml of wine, or 50 grams of 38° liquor (1 liang); 11. Presence or history of drug abuse, drug use, or positive urine screening for drug abuse (including morphine, methylamphetamine, ketamine, dimethyldioxyamphetamine, and THC); 12. History of blood sickness, needle sickness or difficulty in blood collection; 13. Those who have participated in other clinical trials within 3 months before screening, or have not withdrawn from other clinical trials at the time of signing the informed consent, or have participated in screening process of other clinical trials in 7 days; 14. Have lost or donated more than 400mL of blood within 3 months prior to screening; 15. Patients who had undergo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-8;AUC0-840h; | — |
Countries
China
Contacts
Public ContactXiuli Zhao
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed