Diabetic nephropathy
Conditions
Interventions
1:400 mg TBN enteric-coated tablet
2:600 mg TBN enteric-coated tablet
3:1200 mg TBN enteric-coated tablet
4:1800 mg TBN enteric-coated tablet
5:1200 mg TBN enteric-coated tablet and high-fat foods
Sponsors
Haikou Renmin Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Signed and dated a written Informed Consent Form; 2) Subjects should comply with protocol of trail; 3) Within the 6 month of Informed Consent Form signation, subjects would not have pregnancy plan or would like to take efficient contraception; 4) Healthy male and female subjects; 5) Aged 18 to 65 years; 6) Male weighing over 50Kg,Female weighing over 45kg, body weight index within 19.0-28.0kg/m2 (Includ the boundary value).
Exclusion criteria
Exclusion criteria: 1) Subjects with allergic constitution, or history of drug allergy to drug components, same class of TBN, pharmaceutical materials; 2) History of any severe disease or abnormal in respiratory, circulatory, digestive, hematological, endocrine, immunology, dermal, pathergasiology, ophthalmology and otorhinolaryngology, and so on; 3) History of disease which might increase the risk of hemorrhagic, such as acute gastritis or active peptic ulcer disease accompany with bleeding, clinical significance thrombocytopenia or anemia, active pathology bleeding or intracranial hemorrhage; 4) Subjects had gastrointestinal, liver and kidney disease which might influence the pharmacokinetic of drug; 5) Vital signs, body examination, ECG, laboratory examination at clinical significant abnormal results before study (creatinine level of subjects exceed the upper normal value, or liver function test (ALT, AST and bilirubin)> 1.5x ULN); 6) Have serology positive for antibodies to HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) and syphilis at screening; 7) Subjects with a positive result of urinalysis; 8) Have a history of major surgical operation within 6 months, or have a plan to surgical operation within the study period; 9) History of drug abuse, drug used within 3 months before the first dose, or habitual drug used (include Chinese herbal medicine) 10) Smoking over 5 cigarette amount within 3 month, or subjects could not comply with smoking prohibited before the 24 hours of dosing; 11) Alcohol drinking over 14 unite per week within 6 months (1 unite=360 ml beers/45 ml spirit (alcohol concentration over 40%) /150 m wine), subjects could not comply with alcohol drinking prohibited before the 24 hours of dosing or breath alcohol testing positive; 12) Blood donation/hemorrhage =400 ml within 3 months before the first dosing, or blood platelet donation exceed 2 curative dose (1 curative dose= 12 U blood platelet); 13) History of drug use within 14 days; 14) History of clinical trial drug use within 3 months before the first dosing; 15) History of vaccinate use within 3 months before the first dosing; 16) Subjects have the plan of sperm or egg donation within the 6 month of Informed Consent Form signation; 17) The other inappropriate factor which judged by investigator. The female volunteers in accord with the follow items should be excluded: 18) Gestation or suckling periods, or pregnancy tests positive; 19) Female subjects used oral contraceptive within the 30 days before the first dosing; 20) Female subjects used long-acting estrogen, progesterone injection or implant contraceptive within the 6 months before the first dosing; 21) Women of childbearing age have unprotected sex behavior within the 14 days before the first dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine examination;Blood biochemistry;Urine rutine;Blood coagulation;Body examination;ECG; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacoketics;Vital signs; | — |
Countries
China
Contacts
Public ContactXiaoai He
Haikou Renmin Hospital
Outcome results
None listed