diabetes
Conditions
Interventions
Test group:First, receive the investigational drug (Metformin Extended Release Tablets (III)) 2000mg QD, take it after dinner, test the blood drug concentration at various time points within 24 hours,
Sponsors
Department of Endocrinoly, Peking University First Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1) The results of blood routine, urine routine, liver and kidney function and other tests were normal or abnormal without clinical significance, and the researchers judged them to be qualified Chinese healthy subjects; 2) Age 18-50 (including 18 and 50 years old); 3) BMI is 19.0~28.0 kg·m^2; 4) Have the ability to communicate with medical staff and comply with the relevant management regulations of the hospital; 5) Ability to communicate with researchers, understand and comply with research requirements.
Exclusion criteria
Exclusion criteria: 1) A medical history of heart, liver, kidney, digestive tract, respiratory system, nervous system, mental and metabolic disorders; 2) People affecting drug absorption with previous digestive disease or history of digestive system surgery (except appendicitis) ; 3) People with recent history of smoking and alcohol abuse; 4) People used any other drugs within two weeks prior to the start of the trial; 5) People with a clinically significant allergic reaction history, especially drug allergy history, especially those who are allergic to metformin and any ingredients in excipients; 6) People donated blood or lost blood equal to or more than 400 mL in the three months prior to the trial, or intend to donate blood or blood components during the trial or within three months after the trial ends; 7) People who cannot tolerate blood collection by venipuncture; 8) People who cannot guarantee no smoking and no grapefruit juice or any food and drink containing alcohol and xanthines (including chocolate, tea, coffee, cola, etc.) from 48 hours before medication until the last blood collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC 0-24;Tmax;Cmax; | — |
Countries
China
Contacts
Public ContactJunqing Zhang
Department of Endocrinoly, Peking University First Hospital
Outcome results
None listed