Type 2 diabetes mellitus, heart failure and chronic kidney disease
Conditions
Interventions
Experimental group:First, the test formulation (T): Dapagliflozin tablets, then the reference formulation R: Dapagliflozin tablets (Andatang)
Control group:Reference formulation (R): Dapagliflozin tablets (Andatang) Test formulation (T): Dapagliflozin tablets
Sponsors
Shulan (Quzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Before the trial, sign the informed consent form and have a full understanding of the trial content, process and possible adverse reactions; 2. Be capable of completing the research in accordance with the requirements of the test plan; 3. The subjects (including their partners) had no pregnancy plans, sperm or egg donation plans and voluntarily adopted effective non-pharmaceutical contraceptive measures from 2 weeks before self-medication to 6 months after the administration of the last study drug; 4. Healthy male and female subjects aged 18 to 65 years old (including 18 years old and 65 years old); 5. The weight of male subjects should not be less than 50kg and that of female subjects should not be less than 45kg. Body Mass Index (BMI) = weight (kg)/height^2 (m^2). The BMI is within the range of 19.0 to 26.0kg/m^2 (including the critical value); 6. Physical examination, electrocardiogram, laboratory tests, vital signs and other examinations are normal, or the abnormal results are of no clinical significance.
Exclusion criteria
Exclusion criteria: 1. Those with a specific history of allergies (such as asthma, urticaria, eczema, etc.), or those with an allergic constitution (such as allergies to pollen, two or more drugs/foods), or those known to be allergic to the components or analogues of this medicine; 2. Those who have undergone surgery within the 3 months prior to screening or plan to have surgery during the trial period; 3. Those who have donated blood (including component blood donation) or lost a large amount of blood (>=400mL) within 3 months before screening, or have received blood transfusion or used blood products, or plan to donate blood or blood components during the trial or within 3 months after the trial ends; 4. Smoking addiction, that is, those who smoked >=5 cigarettes per day within 3 months before screening, or those who are unable to quit smoking during the trial period; 5. Alcohol addiction, that is, drinking more than 14 units of alcohol per week (1 unit = 360mL of beer or 45mL of 40% alcohol spirits or 150mL of wine) within 3 months before screening, or being unable to quit drinking during the trial period; 6. Those with a positive urine drug test result or a history of drug abuse in the past five years; 7. The following diseases with clinical significance were identified within 12 months prior to the screening, including but not limited to diseases of the nervous/mental system, respiratory system, cardiovascular and cerebrovascular system, digestive tract system, blood and lymphatic system, liver and kidney function, endocrine system, and immune system, and the researcher determined that they were not suitable to participate in this trial; 8. Those who have a history of gastrointestinal diseases that affect the in vivo process of the drug (such as chronic diarrhea, inflammatory bowel disease, gastroesophageal reflux disease) within 12 months prior to screening and are considered by the researchers to still have clinical significance at present, or have severe vomiting or diarrhea within one week before the screening; 9. Have taken any prescription drugs, over-the-counter drugs, any vitamin products, health supplements or traditional Chinese medicine preparations within 14 days prior to screening; 10. Those who have received any vaccine within 28 days prior to screening; 11. Those who have participated in any other drug clinical trials within the three months prior to the screening; 12. Those who cannot tolerate venipuncture, or have a history of fainting from needles or blood, or have difficulty in blood collection; 13. Those who have special dietary requirements (such as vegetarians or lactose intolerant individuals) and cannot follow a uniform diet; 14. Those who consumed excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups, 1 cup = 250mL) every day within the 3 months prior to the screening; 15. Those who consumed special diets (including fruits such as grapefruit, pitaya, mango, pomelo, or related products) or other diets that may affect the absorption, distribution, metabolism, and excretion of the drug within two weeks prior to screening, or take vigorous exercise, or refuse to stop eating the above-mentioned foods during the trial period; 16. Those with difficulty in swallowing; 17. Female subjects who are in the lactation period or have positive serum pregnancy results during the screening period or the trial process; 18. Any clinically abnormal results in the qualitative detection of hepatitis B surface antigen, hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory tests (blood routine, blood biochemistry, urine routine); | — |
Countries
China
Contacts
Public ContactChen Guiling
Shulan (Quzhou) Hospital
Outcome results
None listed