Drug-Drug Interaction Study Between Henagliflozin Proline and Hydrochlorothiazide

NCT06083116 | Completed Phase 1

• 1 other identifier: SHR3824-118
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes in Adults

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Pharmacokinetics parameters of Henagliflozin Proline: Tmax

  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

• Pharmacokinetics parameters of Hydrochlorothiazide: t1/2

  Day 4, Day 14

Study Arms (1)

healthy subjects

EXPERIMENTAL

Drug: Hydrochlorothiazide、Henagliflozin Proline

Interventions

Hydrochlorothiazide、Henagliflozin Proline DRUG

Hydrochlorothiazide and Henagliflozin Proline

healthy subjects

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male;
• Age 18-40 (including threshold);
• Weight ≥ 50 kg, body mass index (BMI): 19.0\~26.0 kg/m2 (including critical value);
• 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;
• Be able to communicate well with the investigators and understand and comply with the requirements in this study.

You may not qualify if:

• Those have allergic constitution, or those with a known history of allergies to study drug or their excipients
• 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.
• Hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive, syphilis antibody positive;
• Previous history of urinary tract infection or genital infection;
• Previous history of hypoglycemia and other important diseases;
• Those who have used other experimental drugs or medical devices within 3 months before screening;
• 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;
• 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;
• Have used any drugs in two weeks prior to taking the study drug;
• Can not comply with the unified dietary arrangement;
• Alcohol abuse, or those who smoke more 5 cigarettes per day in the 6 months prior to screening;
• Positive alcohol breath test,or positive drug screening;
• 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;
• Subjects who are judged by researchers to be unsuitable for participating in this test.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (1)

• 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.

  PMID: 38828023 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 13, 2023
• Study Start: August 28, 2019
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

CN (1)