Type II DiabetesPhase 1NCT05120219
A Study to Assess the Effect of Food on HR20033 and Pharmacokinetic After Multiple Dose in Healthy Volunteers
A Phase 1 study testing FDC tablet in people with Type II Diabetes, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
According to the objective, the trial is constituted by two study groups: one is food effect assessment group, and another is multiple dose pharmacokinetic assessment group. The primary objective is to (1) assess the effect of a meal (light-fat) on the single-dose PK of SHR3824 and metformin administered in the… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- FDC tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2021to 20 Dec 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign the informed consent before the trial, and fully understand the content, process, and possible adverse reactions of the trial, comply with all study requirements;
- Male or female subjects aged 18 to 45 (including 18 and 45).
- Weigh at least 50 kg (for male) and 45 kg (for female), respectively, and have a body mass index (BMI) ≥ 19 and ≤ 26 kg/m2. BMI = weight (kg)/[height (m)]2;
- The investigator evaluate that the subject meets the standards based on medical history, comprehensive physical examination, laboratory examination, 12-lead electrocardiogram, abdominal B-ultrasound, vital signs, etc.
Who cannot join
- Have a birth plan 2 weeks before screening to the end of the follow-up period, or refuse to use medically approved contraceptive measures during this period;
- Drug abusers or those who test positive for drug abuse screening;
- Smokers (an average of 5 or more cigarettes per day); or those who quit smoking did not quit for more than 30 days at the time of screening;
- The average daily alcohol intake in the 1 month before screening exceeds 25 g (for example, 750 mL beer, 250 mL wine or 50 mL low-alcohol liquor); or abstainers have not given up alcohol for more than 30 days at the time of screening;
- People who have consumed grapefruit or fruit juice products within 2 days before administration, any food or drink containing caffeine (such as coffee, tea, chocolate, cola or other carbonated drinks containing caffeine), purine-rich food or alcohol;
- The investigator judges that the subject has a medical condition that affects the absorption, distribution, metabolism, and excretion of the drug, or can reduce compliance, or the investigator considers it inappropriate;
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- Hepatitis B surface antigen (HBsAg) positive, or anti-hepatitis C virus (HCV) antibody positive, or human immunodeficiency virus (HIV) antibody positive, or syphilis antibody positive within 1 month before screening or during the screening period;
- There are any abnormal laboratory test values that are judged by the investigator to be clinically meaningful;
- The 12-lead electrocardiogram (ECG) is abnormal and has clinical significance;
- Female subjects are breastfeeding or have a positive serum pregnancy result during the screening period or the test;
- Any clinical history of serious diseases or diseases or conditions that the investigator believes may affect the test results, including but not limited to the history of circulatory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic diseases;
- People with allergies, including those who are clearly allergic to the study drug or any ingredient in the study drug, allergic to any food ingredient or have special dietary requirements, and cannot comply with a unified diet;
- Those who have undergone any surgery within 3 months before the screening, or who have not recovered after the operation, or who are expected to have surgery or hospitalization plans during the trial period;
- Those who donated blood (or blood loss) within 3 months before screening and donated blood (or blood loss) ≥400 mL, or received blood transfusion;
- Those who have participated in clinical trials of any drug or medical device within 3 months before screening;
- Have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or dietary supplements within 2 weeks before the screening period;
- Have taken metformin and/or SGLT2 inhibitor drugs such as dapagliflozin, empagliflozin, canagliflozin, and empagliflozin within 1 month before administration.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230031
About this study
Official title: A Single-centre, Parallel-cohort, Open-label Study to Assess the Food Effect and Multiple Dose Pharmacokinetic of the HR20033in Healthy Chinese Subjects
According to the objective, the trial is constituted by two study groups: one is food effect assessment group, and another is multiple dose pharmacokinetic assessment group.
The primary objective is to (1) assess the effect of a meal (light-fat) on the single-dose PK of SHR3824 and metformin administered in the HR20033 FDC tablet in healthy Chinese subjects; (2) to characterize the single-dose and steady-state PK of SHR3824 and metformin following administration of the HR20033 FDC tablet to healthy subjects in the fed state.
The secondary objective is to assess in healthy Chinese subjects, the safety and tolerability of the SHR3824 and Metformin after single doses (administered in the fed and fasted states) and multiple doses (administered in the fed state) of the HR20033 FDC tablet.
- Conditions
- Type II Diabetes
- Being tested
- FDC tablet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDC tabletDrug
single HR20033 FDC tablet fed, take orally on an empty stomach and then after meals
FDC tabletDrug
single HR20033 FDC tablet fasted, take orally after meals and then on an empty stomach
FDC tabletDrug
single and multiple doses of HR20033 FDC tablet
| Study group | Role | What they receive |
|---|---|---|
| food effect cohort A | Experimental | Not described Receives: Drug: FDC tablet |
| food effect cohort B | Experimental | Not described Receives: Drug: FDC tablet |
| multiple dose pharmacokinetics | Experimental | Not described Receives: Drug: FDC tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Cmax
Measured: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: AUC0-t
Measured: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: AUC0-inf
Measured: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Cmax
Measured: Based on pre-dose, 0.5-72 hours post-dose on day 1 and Day 11, pre-dose on Day 8, Day 9, Day 10 sampling times
Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: AUC0-inf
Measured: Based on pre-dose, 0.5-72 hours post-dose on day 1 and Day 11, pre-dose on Day 8, Day 9, Day 10 sampling times
Pharmacokinetics parameters of SHR3824 and Metformin after multiple dose: Cmax，ss
Measured: Based on pre-dose, 0.5-72 hours post-dose on day 1 and Day 11, pre-dose on Day 8, Day 9, Day 10 sampling times
Pharmacokinetics parameters of SHR3824 and Metformin after multiple dose: AUCss
Measured: Based on pre-dose, 0.5-72 hours post-dose on day 1 and Day 11, pre-dose on Day 8, Day 9, Day 10 sampling times
Secondary outcomes (8)
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Tmax
Measured: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Vz/F
Measured: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: CL/F
Measured: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: t1/2
Measured: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Tmax
Measured: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Ctrough
Measured: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Racc etc
Measured: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
The incidence and severity of adverse events/serious adverse events
Measured: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start13 Oct 2021
- Primary completion17 Nov 2021
- Study completion20 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia 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
- Randomised
- Intervention model
- Crossover
- Model description
- According to the objective, the trial is constituted by two study groups: one is food effect assessment group, and another is multiple dose pharmacokinetic assessment group. There will be 18 (food effect cohort) and 10 (multiple dose pharmacokinetics) volunteers to receive the treatment, and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic assessments, with safety and tolerability.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120219
- Sponsor's protocol ID
- HR20033-102
- Status last verified
- Nov 2021
- First submitted
- 3 Nov 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Parallel-cohort, Open-label Study to Assess the Food Effect and Multiple Dose Pharmacokinetic of the HR20033in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT05120219
- Acronym / sponsor ID
- HR20033-102
- Conditions
- Type II Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 15 Nov 2021 (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.
According to the objective, the trial is constituted by two study groups: one is food effect assessment group, and another is multiple dose pharmacokinetic assessment group.
The primary objective is to (1) assess the effect of a meal (light-fat) on the single-dose PK of SHR3824 and metformin administered in the HR20033 FDC tablet in healthy Chinese subjects; (2) to characterize the single-dose and steady-state PK of SHR3824 and metformin following administration of the HR20033 FDC tablet to healthy subjects in the fed state.
The secondary objective is to assess in healthy Chinese subjects, the safety and tolerability of the SHR3824 and Metformin after single doses (administered in the fed and fasted states) and multiple doses (administered in the fed state) of the HR20033 FDC tablet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- According to the objective, the trial is constituted by two study groups: one is food effect assessment group, and another is multiple dose pharmacokinetic assessment group. There will be 18 (food effect cohort) and 10 (multiple dose pharmacokinetics) volunteers to receive the treatment, and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic assessments, with safety and tolerability.
| Arm | Type | Receives |
|---|---|---|
| food effect cohort A | Experimental | Drug: FDC tablet |
| food effect cohort B | Experimental | Drug: FDC tablet |
| multiple dose pharmacokinetics | Experimental | Drug: FDC tablet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sign the informed consent before the trial, and fully understand the content, process, and possible adverse reactions of the trial, comply with all study requirements;
- Male or female subjects aged 18 to 45 (including 18 and 45).
- Weigh at least 50 kg (for male) and 45 kg (for female), respectively, and have a body mass index (BMI) ≥ 19 and ≤ 26 kg/m2. BMI = weight (kg)/[height (m)]2;
- The investigator evaluate that the subject meets the standards based on medical history, comprehensive physical examination, laboratory examination, 12-lead electrocardiogram, abdominal B-ultrasound, vital signs, etc.
Key exclusion criteria (17 listed)
- Have a birth plan 2 weeks before screening to the end of the follow-up period, or refuse to use medically approved contraceptive measures during this period;
- Drug abusers or those who test positive for drug abuse screening;
- Smokers (an average of 5 or more cigarettes per day); or those who quit smoking did not quit for more than 30 days at the time of screening;
- The average daily alcohol intake in the 1 month before screening exceeds 25 g (for example, 750 mL beer, 250 mL wine or 50 mL low-alcohol liquor); or abstainers have not given up alcohol for more than 30 days at the time of screening;
- People who have consumed grapefruit or fruit juice products within 2 days before administration, any food or drink containing caffeine (such as coffee, tea, chocolate, cola or other carbonated drinks containing caffeine), purine-rich food or alcohol;
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 |
|---|---|---|
| FDC tabletsingle HR20033 FDC tablet fed, take orally on an empty stomach and then after meals | Drug | food effect cohort A |
| FDC tabletsingle HR20033 FDC tablet fasted, take orally after meals and then on an empty stomach | Drug | food effect cohort B |
| FDC tabletsingle and multiple doses of HR20033 FDC tablet | Drug | multiple dose pharmacokinetics |
Primary outcome
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Cmax
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: AUC0-t
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: AUC0-inf
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Cmax
Time frame: Based on pre-dose, 0.5-72 hours post-dose on day 1 and Day 11, pre-dose on Day 8, Day 9, Day 10 sampling times
Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: AUC0-inf
Time frame: Based on pre-dose, 0.5-72 hours post-dose on day 1 and Day 11, pre-dose on Day 8, Day 9, Day 10 sampling times
Pharmacokinetics parameters of SHR3824 and Metformin after multiple dose: Cmax，ss
Time frame: Based on pre-dose, 0.5-72 hours post-dose on day 1 and Day 11, pre-dose on Day 8, Day 9, Day 10 sampling times
Pharmacokinetics parameters of SHR3824 and Metformin after multiple dose: AUCss
Time frame: Based on pre-dose, 0.5-72 hours post-dose on day 1 and Day 11, pre-dose on Day 8, Day 9, Day 10 sampling times
8 secondary outcomes
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Tmax
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Vz/F
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: CL/F
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: t1/2
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Tmax
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Ctrough
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Racc etc
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
The incidence and severity of adverse events/serious adverse events
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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 FDC tablet in people with Type II Diabetes, run by Shandong Suncadia 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 4 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 24 Nov 2021. 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?
Results are not available in the source record.
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?
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Cmax (time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2021.