Diabetes in AdultsPhase 1NCT06083116
Drug-Drug Interaction Study Between Henagliflozin Proline and Hydrochlorothiazide
A Phase 1 study testing Hydrochlorothiazide、Henagliflozin Proline in people with Diabetes in Adults, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
A single-center, single-arm, open-label, multi-dose, three-period study was conducted in healthy Chinese volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes in Adults
- What is being tested?
- Hydrochlorothiazide、Henagliflozin Proline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2019to 10 Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200031
About this study
Official title: 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.
- Conditions
- Diabetes in Adults
- Being tested
- Hydrochlorothiazide、Henagliflozin Proline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrochlorothiazide、Henagliflozin ProlineDrug
Hydrochlorothiazide and Henagliflozin Proline
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects | Experimental | Not described Receives: Drug: Hydrochlorothiazide、Henagliflozin Proline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady-state pharmacokinetics parameters of Henagliflozin Proline: AUCτ,ss
Measured: Day 10, Day 14
Steady-state pharmacokinetics parameters of Henagliflozin Proline: Css, max
Measured: Day 10, Day 14
Steady-state pharmacokinetics parameters of Hydrochlorothiazide: AUCτ,ss
Measured: Day 4, Day 14
Steady-state pharmacokinetics parameters of Hydrochlorothiazide: Css, max
Measured: Day 4, Day 14
Secondary outcomes (10)
Pharmacokinetics parameters of Henagliflozin Proline: Tmax
Measured: Day 10, Day 14
Pharmacokinetics parameters of Henagliflozin Proline: t1/2
Measured: Day 10, Day 14
Pharmacokinetics parameters of Henagliflozin Proline: CL/F
Measured: Day 10, Day 14
Pharmacokinetics parameters of Hydrochlorothiazide: Tmax
Measured: Day 4, Day 14
Pharmacokinetics parameters of Hydrochlorothiazide: t1/2
Measured: Day 4, Day 14
Pharmacokinetics parameters of Hydrochlorothiazide: CL/F
Measured: Day 4, Day 14
Accumulated urine electrolyte excretion 24 hours after administration
Measured: Day 4, Day 14
Urinary volume at 24 hours after administration
Measured: Day 4, Day 10, Day 14
Accumulated urine glucose excretion within 24 hours after administration
Measured: Day 10, Day 14
Adverse events
Measured: Day 4, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start28 Aug 2019
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes in AdultsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083116
- Sponsor's protocol ID
- SHR3824-118
- Status last verified
- Oct 2023
- First submitted
- 6 Oct 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38828023
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Drug-drug Interaction Between Henagliflozin Proline and Hydrochlorothiazide in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT06083116
- Acronym / sponsor ID
- SHR3824-118
- Conditions
- Diabetes in Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-center, single-arm, open-label, multi-dose, three-period study was conducted in healthy Chinese volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| healthy subjects | Experimental | Drug: Hydrochlorothiazide、Henagliflozin Proline |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrochlorothiazide、Henagliflozin ProlineHydrochlorothiazide and Henagliflozin Proline | Drug | healthy subjects |
Primary outcome
Steady-state pharmacokinetics parameters of Henagliflozin Proline: AUCτ,ss
Time frame: Day 10, Day 14
Steady-state pharmacokinetics parameters of Henagliflozin Proline: Css, max
Time frame: Day 10, Day 14
Steady-state pharmacokinetics parameters of Hydrochlorothiazide: AUCτ,ss
Time frame: Day 4, Day 14
Steady-state pharmacokinetics parameters of Hydrochlorothiazide: Css, max
Time frame: Day 4, Day 14
10 secondary outcomes
Pharmacokinetics parameters of Henagliflozin Proline: Tmax
Time frame: Day 10, Day 14
Pharmacokinetics parameters of Henagliflozin Proline: t1/2
Time frame: Day 10, Day 14
Pharmacokinetics parameters of Henagliflozin Proline: CL/F
Time frame: Day 10, Day 14
Pharmacokinetics parameters of Hydrochlorothiazide: Tmax
Time frame: Day 4, Day 14
Pharmacokinetics parameters of Hydrochlorothiazide: t1/2
Time frame: Day 4, Day 14
Pharmacokinetics parameters of Hydrochlorothiazide: CL/F
Time frame: Day 4, Day 14
Accumulated urine electrolyte excretion 24 hours after administration
Time frame: Day 4, Day 14
Urinary volume at 24 hours after administration
Time frame: Day 4, Day 10, Day 14
Accumulated urine glucose excretion within 24 hours after administration
Time frame: Day 10, Day 14
Adverse events
Time frame: Day 4, Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Derived from this study: PubMed 38828023Chen 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.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes in Adults
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
RecruitingPhase 2
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydrochlorothiazide、Henagliflozin Proline in people with Diabetes in Adults, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steady-state pharmacokinetics parameters of Henagliflozin Proline: AUCτ,ss (time frame: Day 10, Day 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06083116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.