Drug-Drug Interaction Study Between Henagliflozin Proline and Hydrochlorothiazide

NCT ID: NCT06083116

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-28
• Study Completion Date: 2019-10-10

Brief Summary

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

Conditions

Diabetes in Adults

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

healthy subjects

Group Type: EXPERIMENTAL

Hydrochlorothiazide、Henagliflozin Proline

Intervention Type: DRUG

Hydrochlorothiazide and Henagliflozin Proline

Interventions

Hydrochlorothiazide、Henagliflozin Proline

Hydrochlorothiazide and Henagliflozin Proline

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

Chen Q, Yu C, Wu Q, Song R, Liu Y, Feng S, Yu C, Jia J. Evaluation of Drug-Drug Interaction Between Henagliflozin and Hydrochlorothiazide in Healthy Chinese Volunteers. Drug Des Devel Ther. 2024 May 29;18:1855-1864. doi: 10.2147/DDDT.S433377. eCollection 2024.

Reference Type: DERIVED

PMID: 38828023 (View on PubMed)

Other Identifiers

SHR3824-118

Identifier Type: -

Identifier Source: org_study_id