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Completed

NCT Number: NCT06083116

Drug-Drug Interaction Study Between Henagliflozin Proline and Hydrochlorothiazide

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

Completed

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Hydrochlorothiazide、Henagliflozin Proline

Drug

Hydrochlorothiazide and Henagliflozin Proline

Primary outcomes

  1. Steady-state pharmacokinetics parameters of Henagliflozin Proline: AUCτ,ss

    Time frame: Day 10, Day 14

  2. Steady-state pharmacokinetics parameters of Henagliflozin Proline: Css, max

    Time frame: Day 10, Day 14

  3. Steady-state pharmacokinetics parameters of Hydrochlorothiazide: AUCτ,ss

    Time frame: Day 4, Day 14

  4. Steady-state pharmacokinetics parameters of Hydrochlorothiazide: Css, max

    Time frame: Day 4, Day 14

Secondary outcomes

  1. Pharmacokinetics parameters of Henagliflozin Proline: Tmax

    Time frame: Day 10, Day 14

  2. Pharmacokinetics parameters of Henagliflozin Proline: t1/2

    Time frame: Day 10, Day 14

  3. Pharmacokinetics parameters of Henagliflozin Proline: CL/F

    Time frame: Day 10, Day 14

  4. Pharmacokinetics parameters of Hydrochlorothiazide: Tmax

    Time frame: Day 4, Day 14

  5. Pharmacokinetics parameters of Hydrochlorothiazide: t1/2

    Time frame: Day 4, Day 14

  6. Pharmacokinetics parameters of Hydrochlorothiazide: CL/F

    Time frame: Day 4, Day 14

  7. Accumulated urine electrolyte excretion 24 hours after administration

    Time frame: Day 4, Day 14

  8. Urinary volume at 24 hours after administration

    Time frame: Day 4, Day 10, Day 14

  9. Accumulated urine glucose excretion within 24 hours after administration

    Time frame: Day 10, Day 14

  10. Adverse events

    Time frame: Day 4, Day 14

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 13, 2023
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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