None listed
Conditions
Interventions
T- R group: subjects took the test preparation in the first cycle, and took the reference preparation in the second cycle
Sponsors
Hebei General Hospital
Eligibility
Sex/Gender
All
Age
23 Years to 37 Years
Inclusion criteria
Inclusion criteria: 1) Healthy subjects over 18 years old, both male and female; 2) body weight =50.0 kg for male subjects and =45.0 kg for female subjects with body mass index (BMI) between 19.0 and 26.0 kg/m2 (including the cut-off value); 3) have no plans to have children for at least 6 months from 1 month before screening to the last dose of study drug, voluntarily use effective contraceptive methods, and have no plans to donate sperm or eggs; 4) Subjects can communicate well with investigators, fully understand the purpose, nature, methods and possible adverse reactions of the trial, understand and comply with the requirements of this study, volunteer as subjects, and sign the informed consent approved by the ethics committee.
Exclusion criteria
Exclusion criteria: 1) (Inquiry) previous or current problems of circulatory system (e.g., orthostatic hypotension, hypertension, severe arrhythmia), endocrine system (e.g., diabetes mellitus), nervous system (e.g., epilepsy, Parkinson's disease), digestive system (e.g., liver disease), respiratory system (e.g., pulmonary embolism), hematology, immunology, urogenital system, eye, psychiatry (e.g. Previous attempted suicide or suicidal ideation, depression, paranoia, sleep disorders, mania, convulsions), peripheral vascular disease (e.g., deep vein thrombosis), metabolic abnormalities, or any other clinically serious disease that may interfere with the test results; 2) with family history of diabetes or diabetes risk factors such as hyperglycemia; 3) (inquiry) who often felt anxiety, depression, easy to get angry, often insomnia; 4) (to ask) were vaccinated within 1 month before screening, or plan to be vaccinated during the trial; 5) (inquiry) patients with a history of allergy to drugs, food or other substances, or a history of allergic diseases (e.g., anaphylactic shock, angioedema) that the investigator believes is still clinically relevant; 6) (inquiry) underwent surgery within 28 days before screening or planned to undergo surgery during the trial; 7) (inquiry) who had taken any medicine or health product (including Chinese herbal medicine) within 14 days before screening; 8) (inquiry) use of any drugs that inhibit or induce liver metabolism of drugs (e.g., inducers: barbiturates, carbamazepine, phenytoin, rifampicin; Inhibitors: azole antifungs-itraconazole, voriconazole, miconazole, fluconazole, fofluconazole, HIV protease inhibitors - ritonavir, indinavir, lopinavir and ritonavir co-agents, nelfinavir, saquinavir, darunavir, azanavir, fusanavir, telagaprevir, coprixat; SSRI antidepressants, cimetidine, cyclosporine, macrolide clarithromycin, verapamil, diltiazem, quinolones); 9) (inquiry) who had used any clinical trial drug or enrolled in any clinical trial within 3 months before screening or who did not participate in a clinical trial; 10) (inquiry) have donated blood within 3 months before screening, or have lost =400mL of blood within 3 months before the trial, or plan to donate blood, transfuse blood or blood components during the trial; 11) (inquiry) can not tolerate venipuncture and/or have a history of dizzy with blood and needles; 12) (inquiry) used oral contraceptives within 30 days before screening or long-acting estrogen or progestin injections or implants within 6 months before the trial; 13) (inquiry) have had unprotected sex within 14 days before screening (women), or are pregnant or breastfeeding; 14) (inquiry) unable to use non-pharmacological contraceptive methods during the trial; 15) (inquiry) lactose intolerance (cow's milk diarrhea) or special dietary requirements, inability to follow a uniform diet or dysphagia; 16) (inquiry) consuming excessive amounts of tea, coffee or caffeinated beverages (> 8 cups, 1 cup =250 mL) per day in the past 3 months before screening; 17) (inquiry) consumed, or planned to consume, any food or beverage that contains caffeine (e.g., coffee, strong tea, cola, chocolate) or that is rich in xanthine (e.g., sardines, animal liver) within 48 hours before taking the first study drug; 18) (questionnaire) who consumed or planned to consume grapefruit or grapefruar-related citrus fruit (e.g. lime, grapefruit), star fruit, papagua, pomegranate or more within 14 days before taking the first study drug; 19) (e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax; AUC0-t;AUC0-8; Tmax;t1/2; | — |
Secondary
| Measure | Time frame |
|---|---|
| CL/F;Vd/F; | — |
Countries
China
Contacts
Public ContactBAI WANJUN
Hebei General Hospital
Outcome results
None listed