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Drug-Drug Interaction Study Between Henagliflozin Proline and Hydrochlorothiazide

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT06083116
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
1.4
Actual Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Hydrochlorothiazide、Henagliflozin Proline
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Drug-drug Interaction Between Henagliflozin Proline and Hydrochlorothiazide in Healthy Chinese Volunteers
Actual Study Start Date :
Aug 28, 2019
Actual Primary Completion Date :
Oct 10, 2019
Actual Study Completion Date :
Oct 10, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: healthy subjects

Drug: Hydrochlorothiazide、Henagliflozin Proline
Hydrochlorothiazide and Henagliflozin Proline

Outcome Measures

Primary Outcome Measures

  1. Steady-state pharmacokinetics parameters of Henagliflozin Proline: AUCτ,ss [Day 10, Day 14]

  2. Steady-state pharmacokinetics parameters of Henagliflozin Proline: Css, max [Day 10, Day 14]

  3. Steady-state pharmacokinetics parameters of Hydrochlorothiazide: AUCτ,ss [Day 4, Day 14]

  4. Steady-state pharmacokinetics parameters of Hydrochlorothiazide: Css, max [Day 4, Day 14]

Secondary Outcome Measures

  1. Pharmacokinetics parameters of Henagliflozin Proline: Tmax [Day 10, Day 14]

  2. Pharmacokinetics parameters of Henagliflozin Proline: t1/2 [Day 10, Day 14]

  3. Pharmacokinetics parameters of Henagliflozin Proline: CL/F [Day 10, Day 14]

  4. Pharmacokinetics parameters of Hydrochlorothiazide: Tmax [Day 4, Day 14]

  5. Pharmacokinetics parameters of Hydrochlorothiazide: t1/2 [Day 4, Day 14]

  6. Pharmacokinetics parameters of Hydrochlorothiazide: CL/F [Day 4, Day 14]

  7. Accumulated urine electrolyte excretion 24 hours after administration [Day 4, Day 14]

  8. Urinary volume at 24 hours after administration [Day 4, Day 10, Day 14]

  9. Accumulated urine glucose excretion within 24 hours after administration [Day 10, Day 14]

  10. Adverse events [Day 4, Day 14]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Xuhui Central Hospital Shanghai Shanghai China 200031

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT06083116
Other Study ID Numbers:
  • SHR3824-118
First Posted:
Oct 13, 2023
Last Update Posted:
Oct 13, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hydrochlorothiazide

Study Results

No Results Posted as of Oct 13, 2023