none
Conditions
Interventions
Single-arm study:A single dose fasting administration of empagliflozin 10mg
Sponsors
Shanxi Provincial People's Hospital (Fifth Hospital of Shanxi Medical University)
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1) Healthy Chinese adult males aged 18-45 years old ; 2) Weight =50 kg and body mass index (BMI): 19.0~27.0 kg/m2 (including 19.0 and 27.0, BMI=weight/height2); 3) Screening was based on a thorough physical examination, vital signs, 12-lead electrocardiogram, and all required laboratory tests were normal or abnormal without clinical significance (as judged by the clinician), and the subjects were in good health and mental status in the judgment of the investigator; 4) All subjects of childbearing potential have no plans to have children and voluntarily use appropriate and effective contraception from the time of signing the informed start to 3 months after the end of the trial, and have no plans to donate sperm; 5) Subjects are able to communicate smoothly with the investigator, fully understand and strictly comply with the study procedures, participate voluntarily and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Known or suspected hypersensitivity or history of atopic allergic disease (asthma, urticaria, eczematous dermatitis, etc.) or severe allergic sensitization to empagliflozin and its excipient components; 2) Previous history of blood/needle sickness and inability to tolerate blood collection with intravenous indwelling needles; 3) Those with a history of severe systemic diseases such as respiratory, hematologic, endocrine, cardiovascular, immunologic, urinary, gastrointestinal, hepatic, renal, and metabolic abnormalities, or mental disorders; 4) Those with a history of hypoglycemic episodes (e.g., anxiety, dizziness, sweating, tremor, hunger, and inattention) or those with fasting blood glucose <4.0 mmol/L at screening; 5) those with postural hypotension or a systolic blood pressure <90 mmHg; 6) Comorbid dysphagia, or any history of gastrointestinal surgery (e.g., gastric or small bowel resection, cholecystectomy, etc.) that interferes with drug absorption, or comorbid gastrointestinal disorders that interfere with absorption such as atrophic gastritis, esophageal reflux, gastrointestinal hemorrhage, peptic ulcers, diarrhea, vomiting, and nausea; 7) Blood donation or blood loss = 400 mL within 3 months prior to the test or blood donation during the planned test and within 3 months after the end of the test; 8) those who have been vaccinated within 4 weeks prior to the trial or plan to receive any vaccine during the trial or within 1 week after the end of the study; 9) Persons with abnormal/undone results of Hepatitis B surface antigen test, Hepatitis C virus antibody, human immunodeficiency virus antibody assay, and syphilis spirochete-specific antibody test; 10) Those who have used prescription drugs, over-the-counter drugs, health supplements, herbal medicines or Chinese medicines within 2 weeks prior to the trial (except topical topical medicines for a short period of time); 11) Those who have used any drugs affecting renal metabolism (e.g., amino acid glycosides, sulfonamides, other penicillins and cephalosporins, quinolones, cisplatin and other antitumor drugs, non-steroidal analgesic and anti-inflammatory drugs such as acetaminophen, antiepileptic drugs such as phenytoin sodium and other angiographic drugs such as metals and their complexes, etc.) in the 4 weeks prior to the test; 12) Those who have regularly consumed alcohol within 3 months prior to the trial, i.e., more than 2 units of alcohol per day on average (1 unit = 360 mL of beer or 45 mL of spirits of 40% alcohol by volume or 150 mL of wine) or those who have an abnormal/undone alcohol breath test result on admission; 13) Those who have smoked an average of more than 5 cigarettes per day during the 3 months prior to the trial or who are unable to give up smoking during the entire trial period; 14) a history of substance abuse within 12 months prior to the trial or an abnormal/undone urine drug screen result at admission 15) Consumption of excessive (more than 8 cups a day, 1 cup = 250 mL) tea, coffee, or caffeinated beverages in the 3 months prior to the trial or who plan to ingest or are unable to stop ingesting the above diets during the trial; 16) Persons with special dietary requirements who are unable to comply with a uniform diet or who are lactose intolerant; 17) Consumption of special foods within 48 hours prior to the first dose, including dragon fruit, mango, grapefruit, pomelo or fruit juice of the above fruits, xanthine-rich foods (e.g., animal offal, fish),
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine a1-microglobulin;Urine ß2-microglobulin;Plasma renin;Plasma angiotensin II;Plasma aldosterone; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine glucose;Urine uric acid ;Urine PH;Urine Na+;Blood glucose;Insulin;Uric acid;Serum creatinine;Blood urea nitrogen;Blood presure;Serum Bicarbonate;Serum Na+;Serum K+;Serum Cl-; | — |
Countries
China
Contacts
Public ContactRongshan Li
Shanxi Provincial People's Hospital (Fifth Hospital of Shanxi Medical University)
Outcome results
None listed