Clinical trial NCT06083116: Drug-Drug Interaction Study Between Henagliflozin Proline and Hydrochlorothiazide
Official title: Evaluation of Drug-drug Interaction Between Henagliflozin Proline and Hydrochlorothiazide in Healthy Chinese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes in Adults
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-13
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

Brief summary: A single-center, single-arm, open-label, multi-dose, three-period study was conducted in healthy Chinese volunteers.


Eligibility criteria: 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.

Primary outcomes:
measure: Steady-state pharmacokinetics parameters of Henagliflozin Proline: AUCτ,ss
timeFrame: Day 10, Day 14
measure: Steady-state pharmacokinetics parameters of Henagliflozin Proline: Css, max
timeFrame: Day 10, Day 14
measure: Steady-state pharmacokinetics parameters of Hydrochlorothiazide: AUCτ,ss
timeFrame: Day 4, Day 14
measure: Steady-state pharmacokinetics parameters of Hydrochlorothiazide: Css, max
timeFrame: Day 4, Day 14
Secondary outcomes:
measure: Pharmacokinetics parameters of Henagliflozin Proline: Tmax
timeFrame: Day 10, Day 14
measure: Pharmacokinetics parameters of Henagliflozin Proline: t1/2
timeFrame: Day 10, Day 14
measure: Pharmacokinetics parameters of Henagliflozin Proline: CL/F
timeFrame: Day 10, Day 14
measure: Pharmacokinetics parameters of Hydrochlorothiazide: Tmax
timeFrame: Day 4, Day 14
measure: Pharmacokinetics parameters of Hydrochlorothiazide: t1/2
timeFrame: Day 4, Day 14
measure: Pharmacokinetics parameters of Hydrochlorothiazide: CL/F
timeFrame: Day 4, Day 14
measure: Accumulated urine electrolyte excretion 24 hours after administration
timeFrame: Day 4, Day 14
measure: Urinary volume at 24 hours after administration
timeFrame: Day 4, Day 10, Day 14
measure: Accumulated urine glucose excretion within 24 hours after administration
timeFrame: Day 10, Day 14
measure: Adverse events
timeFrame: Day 4, Day 14
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital
state: Shanghai
Study officials:
References: