Diabetes in Adults
Conditions
Brief summary
A single-center, single-arm, open-label, multi-dose, three-period study was conducted in healthy Chinese volunteers.
Interventions
DRUGHydrochlorothiazide、Henagliflozin Proline
Hydrochlorothiazide and Henagliflozin Proline
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Evaluation of drug-drug interaction between Henagliflozin Proline and Hydrochlorothiazide. A single-center, single-arm, open-label, multi-dose, three-period study was conducted in healthy Chinese volunteers.
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male; 2. Age 18-40 (including threshold); 3. Weight ≥ 50 kg, body mass index (BMI): 19.0\ 26.0 kg/m2 (including critical value); 4. Volunteers (and their spouses) must not plan for childbearing or sperm donation within one month prior to signing the informed consent form and from the period of taking the research drug until three months after stopping it; 5. Be able to communicate well with the investigators and understand and comply with the requirements in this study.
Exclusion criteria
1. Those have allergic constitution, or those with a known history of allergies to study drug or their excipients 2. Physical examination, vital signs, blood-routine examination, blood biochemistry, infectious disease screening, coagulation function, urine-routine examination, chest x-ray, B ultrasound and other examination results are abnormal and judged by the research doctor as clinically significant. 3. Hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive, syphilis antibody positive; 4. Previous history of urinary tract infection or genital infection; 5. Previous history of hypoglycemia and other important diseases; 6. Those who have used other experimental drugs or medical devices within 3 months before screening; 7. Those who seek medical within 3 months prior to screening, which are judged by the research doctor to be unfit for participants;Those who have undergone any surgery within 6 months prior to screening; 8. Those who donate blood or other reasons of bleeding cause the total loss of blood more than 400mL or receive blood transfusions within 3 months before screening; 9. Have used any drugs in two weeks prior to taking the study drug; 10. Can not comply with the unified dietary arrangement; 11. Alcohol abuse, or those who smoke more 5 cigarettes per day in the 6 months prior to screening; 12. Positive alcohol breath test,or positive drug screening; 13. From 3 days before taking the study drug, subjects have xanthine-rich beverages or food, or grapefruit and other fruits or juices that may affect metabolism; 14. Subjects who are judged by researchers to be unsuitable for participating in this test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Steady-state pharmacokinetics parameters of Henagliflozin Proline: AUCτ,ss | Day 10, Day 14 |
| Steady-state pharmacokinetics parameters of Henagliflozin Proline: Css, max | Day 10, Day 14 |
| Steady-state pharmacokinetics parameters of Hydrochlorothiazide: AUCτ,ss | Day 4, Day 14 |
| Steady-state pharmacokinetics parameters of Hydrochlorothiazide: Css, max | Day 4, Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics parameters of Hydrochlorothiazide: t1/2 | Day 4, Day 14 |
| Pharmacokinetics parameters of Hydrochlorothiazide: CL/F | Day 4, Day 14 |
| Accumulated urine electrolyte excretion 24 hours after administration | Day 4, Day 14 |
| Pharmacokinetics parameters of Henagliflozin Proline: Tmax | Day 10, Day 14 |
| Accumulated urine glucose excretion within 24 hours after administration | Day 10, Day 14 |
| Adverse events | Day 4, Day 14 |
| Urinary volume at 24 hours after administration | Day 4, Day 10, Day 14 |
| Pharmacokinetics parameters of Henagliflozin Proline: t1/2 | Day 10, Day 14 |
| Pharmacokinetics parameters of Henagliflozin Proline: CL/F | Day 10, Day 14 |
| Pharmacokinetics parameters of Hydrochlorothiazide: Tmax | Day 4, Day 14 |
Countries
China
Outcome results
None listed