Diabetes
Conditions
Interventions
Group A:Phase I: took sucrose water orally alone in fasting state
Phase II: took sucrose water and the test preparation simultaneously
Phase III: took sucrose water and the reference preparation simultaneously.
Group B:Phase I: took sucrose water and the test preparation simultaneously in fasting state
Phase II: took sucrose water and the reference preparation simultaneously
Phase III: took sucrose water orally alone.
Group C:Phase I: took sucrose water and the reference preparation simultaneously in fasting state
Phase II: took sucrose water orally alone
Phase III: took sucrose water and the test preparation simultaneously.
Sponsors
Phase I Clinical Trial Research Center of Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Healthy volunteers, aged >= 18 years; 2) Gender: both men and women 3) The body mass index (BMI) was 19.0~26.0 kg/m2 (including the critical value), with male body weight >= 50.0 kg and female body weight >= 45.0 kg 4) Fasting blood glucose <= 6.10mmol /L, HbA1c < 5.7%; 5) Subjects must give informed consent to the study prior to the study and voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1) Have difficulty swallowing, or have gastrointestinal, liver, or kidney diseases that affect drug absorption or metabolism untill now. 2) Have the history of herpes zoster that breaks out repeatedly, or history of herpes zoster of spread sex, or history of herpes simplex of spread sex. 3) Family history of diabetes or history of hypoglycemia. 4) Allergic constitution, especially allergic to this product, excipients and the analogue. 5) A history of any clinically significant disease, or a history of clinically significant disease as determined by the investigator. 6) Have received live or attenuated live vaccines within 6 weeks of the first administration or plan to receive these vaccines during the course of treatment or within 6 weeks after the last study drug administration. 7) Unable to communicate or cooperate with health care workers due to neurological, mental or language problems. 8) Venous blood difficulty sufferer, or have the history of fainting needle or fainting blood. 9) People who drink too much tea, coffee or caffeinated drinks (more than 8 cups a day, 1 cup = 200 mL) in the past. 10) Previous heavy drinking, or regular drinking in the 6 months prior to the trial. 11) A history of substance abuse/dependence or drug abuse within 1 year prior to the first use of drugs. 12) Previous use of hormone replacement therapy within 3 months prior to first use (dehormonal contraceptives). 13) Those who have participated in any drug clinical trial and taken the experimental drug within 3 months before the first drug administration. 14) The daily smoking amount is more than 5 cigarettes within 3 months before the first medication. 15) Blood donation or blood loss >= 200 mL within 3 months before the first medication, or plan to donate blood or blood composition during the trial or within 3 months after the trial. 16) Within 30 days before the first administration of the drug, use coleidamide, any known intestinal adsorbent and digestive enzyme preparations, immunosuppressive drugs (such as azathioprine, tacrolimus, cyclosporine A), or any drug that interacts with acarbose 17) Failure to follow a uniform diet (e.g. taking sucrose water on an empty stomach). 18) Women who were pregnant or breastfeeding, or men or women who had planned pregnancy or were unwilling to use barrier contraception throughout the trial period, and women who did not use barrier contraception during the 2 weeks prior to the first dose. 19) Physical examination, vital signs examination, laboratory examination (blood routine, urine routine, blood biochemistry, blood coagulation function, etc.) and 12-lead electrocardiogram examination results are of clinical significance and have an impact on the evaluation of this test. 20) Positive results of hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), treponema pallida antibody (TPAb/RPR) or human immunodeficiency virus antibody (HIV). 21) Abnormal breath detection of alcohol (acceptable range: 0~3 mg/100 mL). 22) With positive drug abuse test. 23) Those who are considered unfit to participate in the study or unable to participate in the study for their own reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactXu Pingsheng
Xiangya Hospital Central South University
Outcome results
None listed