Type 2 diabetes
Conditions
Interventions
fasting congdition(pre-test) :After fasting overnight for at least 10 hours, one tablet of the test preparation or one tablet of the reference preparation was taken with 240mL water on an empty stomac
fasting congdition:After fasting overnight for at least 10 hours, one tablet of the test preparation or one tablet of the reference preparation was taken with 240mL water on an empty stomach in the mo
fed condtion :After fasting overnight for at least 10 hours, eat a high-fat and high-calorie standard meal 30 minutes before taking 1 test preparation or the reference preparation with 240mL water in
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 and above; (2) Gender requirement: at random, the number of single sex subjects should not be less than 1/3 of the total number of cases; (3) Male subjects were not less than 50 kg in weight and female subjects were not less than 45 kg in weight; body mass index (BMI)= body weight (kg)/ height 2(m2) in the range of 19-26 kg/m2;; (4) Vital signs, Physical examination and the clinical laboratory examination were all normal or abnormal. The results of virology indexes were negative; (5) Subjects (including men) had no birth plan and no sperm or egg donation plan for 3 months from the screening period to the end of the study, meanwhile they were willing and able to use medically accepted and reliable contraception during the trial; (6) Volunteer to participate in the trial, and sign a written informed consent prior to the trial.
Exclusion criteria
Exclusion criteria: (1) Allergic constitution or allergic history; (2) With dysphagia or any gastrointestinal disorder that affects drug absorption; (3) Women who were pregnant, lactating, or planning to become pregnant during the trial and throughout the trial. Men or women who were unwilling to use barrier contraception for one month after the trial; (4) Venous blood collection difficulties, or have a history of needle, blood; (5) To participate in any clinical drug trial within 3 months prior to administration; (6) Has any clinical history of serious disease, such as cardiovascular, endocrine or pulmonary, hematological, immunological or metabolic abnormalities; (7) Use hormone replacement therapy within 3 months prior to administration, except Hormonal birth control pills; (8) Blood or massive bleeding (=200 mL) was presented within 3 months prior to administration ,or planned to donate blood or blood composition during the study period or within 3 months after the end of the study; (9) Unable to communicate or cooperate with investigators due to neurological, mental or language disorders; (10) Failure to follow a uniform diet; (11) Smoked more than 5 cigarettes per day in the 3 months before the trial, or couldn't stop smoking during the trial period; (12) Previous long-term excessive consumption (more than 8 cups per day, 1 cup =200mL) of tea, coffee or caffeine; (13) History of alcohol abuse in the 6 months prior to the trial; (14) History of substance abuse/dependence within 1 year prior to the trial; (15) The relevant virology test was positive; (16) The results of physical examination, vital signs examination, laboratory examination, and electrocardiogram were judged as abnormal and clinically significance, which influence the trial; (17) Used any medicine (including prescription, over-the-counter, herbal, etc.) or health care products within 14 days before the first use; (18) Use of any drugs that inhibit or induce the liver's metabolism within 30 days prior to initial administration; (19) Consume any food or beverage (e.g. coffee, strong tea, chocolate, etc.) containing caffeine, alcohol, xanthine or grapefruit within 48 hours of the first dose; (20) Abnormal alcohol breath detection (acceptable range: 0~3mg/100mL); (21) Has a positive urine drug screening; (22) The researchers considered that the subjects should not participate in the experiment, or the subjects could not participate in the experiment due to their own reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Contacts
Public ContactXu Pingsheng
Xiangya Hospital Central South University
Outcome results
None listed