None listed
Conditions
Interventions
Fasting T-R group :Subjects fasted overnight for at least 10 hours before taking the drug. After a blank blood sample was collected in the morning of the administration day, the test preparation was o
Fasting R-T group :Subjects fasted overnight for at least 10 hours before taking the drug. After a blank blood sample was collected in the morning of the administration day, the reference preparation
High-fat postprandial T-R group :Subjects fasted overnight for at least 10 hours before taking the drug. After a blank blood sample was collected in the morning on the day of administration, the test
High-fat postprandial R-T group :Subjects fasted overnight for at least 10 hours before taking the drug. After a blank blood sample was collected in the morning on the day of administration, the refer
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects must meet all the following inclusion criteria before they can be included in this study: 1. Voluntarily participate and sign the informed consent form; 2. Healthy male or female; 3. Aged 18 years and above; 4. Female weight >= 45.0kg, male weight >= 50.0 kg, body mass index (BMI) = weight (kg)/height 2 (m2), body mass index is 19.0-26.0 kg/m2, including the critical value.
Exclusion criteria
Exclusion criteria: Subjects who met any of the following exclusion criteria could not be included in this study: 1. Those with clinical significance and abnormal physical examination, blood routine examination, blood biochemistry, urine routine examination, 12 lead ECG, virological examination, blood coagulation function examination, etc.; 2. Severe heart, lung, liver, kidney, blood, gastrointestinal, endocrine, immune, skin patients with disease, nervous or mental disease or other medical history or existing above diseases are not suitable for this study according to the judgment of the researcher; 3. Systolic blood pressure = 5 cigarettes a day within 3 months before screening or those who did not agree to quit smoking during the trial; 13. Those who have used any drugs within 14 days before screening (including prescription drugs, over-the-counter drugs, Chinese herbal medicine and health care products); 14. Those who have used any drugs that inhibit or induce the metabolism of drugs in the liver within 30 days before taking the study drug for the first time (such as inducers-barbiturates, carbamazepine, phenytoin sodium, rifampicin; inhibitors-SSRI antidepressants, cimetidine, cyclosporine, macrolides, verapamil, quinolones, pyrrole antifungal drugs, HIV protease inhibitors, etc.); 15. Those vaccinated within 14 days before screening or during the planned trial; 16. Those who used any clinical trial drug or enrolled in any drug clinical trial 3 months before screening; 17. Total blood loss >= 400 mL due to blood donation or bleeding from other reasons within 3 months before screening (except female physiological blood loss); 18. Pregnant or lactating women and male subjects (or their partners) or female subjects have pregnancy plans from 3 weeks before screening to 3 months after the end of the trial, and are unwilling to use a medically recognized non drug contraceptive measure (such as intrauterine device or condom) during the trial; 19. Other subjects considered unsuitable by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of empagliflozin in plasma; | — |
Countries
China
Contacts
Public ContactShaojun Shi
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed