Drug-Drug Interaction Study Between Henagliflozin Proline and Hydrochlorothiazide

Phase 1

Completed

• Conditions: Diabetes in Adults
• Interventions: Drug: Hydrochlorothiazide、Henagliflozin Proline

• Registration Number: NCT06083116
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-28
• Primary Completion: 2019-10-10
• Study Completion: 2019-10-10
• Status Verified: 2023-10
• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-10-12
• Last Update Submitted: 2023-10-12
• Study First Posted: 2023-10-13
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
healthy subjects	Hydrochlorothiazide、Henagliflozin Proline	-

Primary Outcome Measures

Name	Time	Method
Steady-state pharmacokinetics parameters of Hydrochlorothiazide: Css, max	Day 4, Day 14
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

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics parameters of Henagliflozin Proline: t1/2	Day 10, Day 14
Pharmacokinetics parameters of Hydrochlorothiazide: Tmax	Day 4, Day 14
Pharmacokinetics parameters of Hydrochlorothiazide: t1/2	Day 4, Day 14
Pharmacokinetics parameters of Henagliflozin Proline: Tmax	Day 10, Day 14
Pharmacokinetics parameters of Henagliflozin Proline: CL/F	Day 10, Day 14
Pharmacokinetics parameters of Hydrochlorothiazide: CL/F	Day 4, Day 14
Adverse events	Day 4, Day 14
Accumulated urine electrolyte excretion 24 hours after administration	Day 4, Day 14
Urinary volume at 24 hours after administration	Day 4, Day 10, Day 14
Accumulated urine glucose excretion within 24 hours after administration	Day 10, Day 14

Trial Locations

Locations (1)

Shanghai Xuhui Central Hospital; 🇨🇳 Shanghai, Shanghai, China