hyperglycemia
Conditions
Interventions
Group 1:Metformin Hydrochloride Tablets - HTD1801 Capsules - HTD1801 Capsules Combined with Metformin
Group 2:HTD1801 Capsules - HTD1801 Capsules Combined with Metformin - Metformin Hydrochloride Tablets
Group 3:HTD1801 Capsules Combined with Metformin - Metformin Hydrochloride Tablets - HTD1801 Capsules
Sponsors
The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. The volunteer subjects should sign the informed consent before the test and have a full understanding of the test content, process, and possible adverse reactions; Volunteer to participate and be able to complete the study according to the protocol; 2. Male healthy subjects aged 18-45 years (including 18 and 45 years); 3. The body weight should not be less than 50.0 kg. Body mass index (BMI) was in the range of 19.0-26.0 kg/m2 (including the cut-off value); 4. The subjects and their female partners are willing to use the screening before 2 weeks to test drugs within 6 months after the last delivery without family planning and voluntarily to take effective contraceptive measures and no donor program, and ensure the 2 weeks to test before use drug 1 month after the last dose of sex with one or more than one nondrug contraception.
Exclusion criteria
Exclusion criteria: 1. Diseases that have occurred or are occurring before screening and have clinical abnormalities that need to be excluded, including but not limited to diseases of nervous/mental system, respiratory system, cardiovascular and cerebrovascular system, digestive system (any gastrointestinal disease history that affects drug absorption), blood and lymphatic system, urinary system, endocrine system, immune system; 2. Patients with abnormal weight changes within 8 weeks before screening; 3. Patients with hypoglycemia history, severe unconscious hypoglycemia history, or glucose metabolism disorder; 4. Patients suffering from any contraindications described in the instructions for metformin hydrochloride tablets (Gewarz) (see Appendix 6 for details); 5. Screened patients who had undergone surgery within 3 months before or planned to undergo surgery during the study, and those who had undergone surgery that would affect drug absorption, distribution, metabolism, and excretion; 6. Use of any drugs that inhibit or induce liver metabolism (e.g., liver enzyme inducers, barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole) within 28 days before screening; Liver enzyme inhibitors, Selective serotonin reuptake inhibitors (SSRI) antidepressants, cimetidine, diltiazem, large ring lactone class, nitro imidazoles, sedative hypnotics, verapamil, fluoroquinolone, antihistamines, statins) or transporter (p - glycoprotein [p - gp], 2 [OCT2] organic cation transporter, explosive and toxic compound outside transport eggs White 1[MATE1], multidrug and toxic compound efflux transporter 2K[MATE2K]) inducer or inhibitor; 7. Have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines and dietary supplements in the 14 days prior to screening; 8. Patients who developed acute illness from the screening stage to the study medication; 9. Those with a history of drug abuse or drug use within 6 months before screening; 10. People with allergic history to food and drugs, especially those who are known to be allergic to oral hypoglycemic drugs such as HTD1801, BBR, UDCA and metformin, or their excipients or allergic constitution; 11. Those who were vaccinated within 1 month prior to screening or planned to be vaccinated during the trial; 12. Donors whose blood donation included component blood or massive blood loss (=400 mL) within 3 months before screening, or who planned to donate blood during the trial; 13. Those who have been enrolled in other drug clinical trials and received drugs in clinical trials within 3 months before screening; 14. Those who cannot tolerate venipuncture or have a history of needle sickness or blood sickness; 15. Patients with dysphagia; 16. Smokers who smoked more than 5 cigarettes per day in the 3 months before screening, or who could not stop using any tobacco products during the test; 17. Those who consumed an average of more than 14 units of alcohol per week (1 unit ˜360 mL beer or 45 mL 40% spirits or 150 mL wine) during the 3 months prior to screening, or who could not abstain during the trial; 18. Those who consumed excessive amounts of tea, coffee, and/or caffeinated beverages (more than 8 cups on average, 1 cup ˜250 mL) per day in the previous 3 months were screened; 19. Within 48 h before eating or drinking a dragon fruit, mango, pomelo, carambola, or by the preparation of food or drink, or food containing xanthine, caffeine or alcohol or drinks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;adverse event;vital signs;laboratory inspection;12 lead ECG; | — |
Countries
China
Contacts
Public ContactWei Hu
Drug Clinical Research Center, The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed