None, Healthy adults
Conditions
Interventions
Group A:Sucrose-Sucrose+TEST 100mg-Sucrose-Sucrose+CONTROL 100mg
Group B:Sucrose-Sucrose+CONTROL 100mg-Sucrose-Sucrose+TEST 100mg
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Subjects aged 18 to 65 years with appropriate gender ratio; (2) BMI within 19~24 (including the border) and the body weight of men not less than 50kg, and that of women not less than 45kg; (3) Screening tests, including medical history, vital signs, physical examination, laboratory examination (blood test, urine test, stool test, blood biochemistry, blood electrolyte, infectious disease markers, glucose tolerance test, glycosylated hemoglobin, thyroid hormones (FT3, FT4 and TSH)), ECG, X-Ray chest radiography and abdominal sonography, to determine the subjects in good health; (4) Medically acceptable or reliable contraceptive measures; (5) Subjects understand the test procedures, voluntarily comply with the requirements of the test program, and agree to participate in the test by signing the informed consent approved by ethics committee.
Exclusion criteria
Exclusion criteria: (1) Allergy to foods and any component of the drug used in this study; (2) Female volunteers with positive HCG, female volunteers who are breast-feeding, or female volunteers who have used oral contraceptives within 2 weeks; (3) Patients with previous or current abnormal diseases of the circulatory system, respiratory system, digestive system, nervous system, blood system, immunology, psychiatry, endocrine and metabolism, which are considered clinically significant by researchers; Or are suffering from any other disease that may interfere with the results of the study; (4) Those who are easily affected by body position and suffer from movement disorder, fainting or loss of consciousness; (5) Those who have previously undergone gastrointestinal surgery (except minors who have undergone appendectomy and herniorrhaphy); (6) Systolic blood pressure =140mmHg and 1 ULN, renal function: Cr, BUN > 1 ULN; (9) Abnormal test results of infectious diseases markers, including HIV, hepatitis b, hepatitis c virus and treponema pallidus; (10) Abnormal glucose tolerance test: fasting venous plasma glucose =5.9mmol/L, OGTT 0.5h venous glucose =8.6mmol/L, OGTT 1h venous glucose =10.0mmol/L, OGTT 2h venous glucose =7.8mmol/L, two of which are considered to be abnormal. OGTT 0.5h insulin =120mU/L, 1.0h insulin =110mU/L, 2.0h insulin =60mU/L, with clinical significance determined by endocrinologist or main researcher; (11) HbA1c>6.1% with clinical significance; (12) Abnormal thyroid hormone examination with clinical significance: normal range FT3 (3.60 ~ 7.50 pmol/L), FT4 (12.0 ~ 22.0 pmol/L), TSH (0.27 ~ 4.2mu /L); (13) Those have used any drug (including OTC, traditional Chinese medicine, etc.) within 2 weeks before the intervention, or have experienced a time < 10 half-lives after taking the drug; (14) Blood donation history or clinical blood collection history within 30 days before the intervention; (15) Heavy drinkers or regular drinkers within 6 months prior to the study, i.e., those who consumed more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine); (16) Drug abusers or those who have used drugs 3 months before the intervention; (17) Regular smokers (those who smoke more than 5 cigarettes per day in recent 3 months); (18) Those with reproductive needs during the test period and within 6 months after the study; (19) Participated in other clinical trials within 3 months before the intervention; (20) Those who plan to perform surgery and take drugs during the trial period; (21) Subjects deemed by the researcher to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose; | — |
Countries
China
Contacts
Public ContactJia Miao
West China Hospital, Sichuan University
Outcome results
None listed