None listed
Conditions
Interventions
group 1:4 mg pitavastatin calcium+4mg repaglinide
group 2:Placebo+4mg repaglinide
Sponsors
Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
Male
Age
21 Years to 25 Years
Inclusion criteria
Inclusion criteria: 1) Subjects must be able to read and understand the contents of informed consent,and signed informed consent; 2) Age 18-55 years old, male, no more than 10 years in age difference with the same batch (including the boundary values); 3) Body weight > 50kg, the subjects body mass index (BMI) between 19-25kg/m2 (BMI = weight (kg)/height 2 (m2)), including the boundary values, the same batch weight difference should not be great; 4) No history of alcohol abuse or drug abuse, non-smokers; 5) Based on physical examination, medical history, vital signs, ECG and clinical laboratory results, the researchers believe that subjects are in good health, no history of mood, liver, kidney, gastrointestinal tract, nervous system, metabolic disorders and other mental disorders; They are ascertained to be healthy by physical examination such as blood pressure, heart rate, ECG, respiratory status, liver and kidney function and so on; 6) Subjects can be able to make good communication with researchers and complete research in accordance with the provisions of study.
Exclusion criteria
Exclusion criteria: 1) It is known that there are allergies for active pharmaceutical ingredients or excipients; 2) Specific allergic history (asthma, urticaria, eczema, dermatitis), arrhythmia, bradycardia, hypotension, coronary heart disease, bronchial and cardiovascular diseases, diabetes, hyperthyroidism, Parkinson's disease, epilepsy , tremor, paralysis and any other diseases or physiological conditions interfering test results; 3) Subjects are receiving or have been received gastrointestinal problems, seizures, gastrointestinal ulcers, urinary tract infarction, mechanical intestinal obstruction, ureteral spasm, biliary tract disease and other treatment of depressive disorders or liver disease; 4) It is known that the factors can affect the venous blood of severe bleeding; 5) Some gastrointestinal tract diseases can affect drug absorption or metabolism; 6) Subjects have the history of drug abuse or positive urine drug test results within the past five years; 7) The combined use of drugs that affect glucose metabolism, such as corticosteroids and so on; 8) It is known to have used drugs that damage an organ within three months; 9) It is known to have used other drugs that may affect the metabolism of hypoglycemic drugs within 14 days before the test (such as monoamine oxidase inhibitors, non-selective beta-blockers, ACEI, non-steroidal anti-inflammatory drugs, salicylates, octreotide, alcohol, anabolic growth hormone, oral contraceptives, thiazide drugs, corticosteroids, danazol, thyroid hormones, sympathomimetics, ketoconazole, itraconazole, erythromycin, fluconazole, and other azole anti-fungal, rifampicin, phenytoin, trimethoprim, cyclosporine, macrolide antibiotics erythromycin and clarithromycin, cimetidine, indomethacin,etc); 10) A serious loss of blood or donating blood or plasma (300mL) within 30 days before the test; 11) Primary disease in vital organs; 12) Regular smokers or drinkers, that drinking more than 28 units of alcohol per week (1 unit: 285ml beer or 1 glass of wine or 25ml spirits) or weekly smoking over two or more cigarette; 13) Often using sedatives, sleeping pills, tranquilizers or other addictive drugs; 14) The researchers believe that some subjects should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Repaglinide Concentration in Plasm; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood glucose concentration; | — |
Countries
China
Contacts
Public ContactGuo-ping Yang
Outcome results
None listed