Drug-Drug Interaction Study Between Henagliflozin Proline and Hydrochlorothiazide

Evaluation of Drug-drug Interaction Between Henagliflozin Proline and Hydrochlorothiazide in Healthy Chinese Volunteers

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

Study Overview

• Status: Completed
• Conditions: Diabetes in Adults
• Intervention / Treatment: Drug: Hydrochlorothiazide、Henagliflozin Proline

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Shanghai Xuhui Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: healthy subjects	Drug: Hydrochlorothiazide、Henagliflozin Proline; Hydrochlorothiazide and Henagliflozin Proline

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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
Pharmacokinetics parameters of Hydrochlorothiazide: CL/F	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
Adverse events	Day 4, Day 14

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2019
• Primary Completion (Actual): October 10, 2019
• Study Completion (Actual): October 10, 2019

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Chloride Symporter Inhibitors; Hydrochlorothiazide
• Other Study ID Numbers: SHR3824-118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No