Type II DiabetesPhase 1NCT05108350
A Study to Assess the Bioequivalence of Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Healthy Chinese Subjects
A Phase 1 study testing T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR and T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR in people with Type II Diabetes, run by Shandong Suncadia Medicine Co., Ltd..
Trial summary
The trial is to assess the bioequivalence between HR20033 FDC tablet and co-administration of SHR3824 tablets and metformin XR tablets. The primary objective is to evaluate bioequivalence of SHR3824 and Metformin in healthy Chinese subjects in the fed state. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR and T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 9 Nov 2021to 10 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 50 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;
- Must be able to communicate with the investigator, understand and comply with all study requirements;
- Subject (include their fere) must have not pregnancy plan from 2 weeks prior to dose administration to 6 months after last dose administration and must use effective form of birth control;
- Male or female subjects aged 18 to 50 (including 18 and 50);
- Weigh at least 50 kg (for male) and 45 kg (for female), respectively, and have a body mass index (BMI) ≥ 18 and <28 kg/m2. BMI = weight (kg)/[height (m)]2;
- No clinically significant deviation from normal in medical history, vital signs, physical examination.
Who cannot join
- Regular smoker within 3 months prior to study drug administration, or quitting smoking less than 30 days until screening;
- History of allergy to test drugs, allergic constitution (multiple drug and food allergies);
- A history of alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); those who have abstained from alcohol have not quit for 30 days at the time of screening;
- Donate blood or lose a lot of blood (>450mL) within three months before screening;
- Take any drugs that alter liver enzyme activity 28 days before screening;
- Take any prescription drugs, over-the-counter drugs, any vitamin products or herbal medicines within 14 days before screening;
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- Those who have taken a special diet (including pitaya, mango, grapefruit, etc.) or exercised vigorously within 2 weeks before screening, or other factors that affect drug absorption, distribution, metabolism, and excretion;
- Combine the following inhibitors or inducers of CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone;
- Significant changes in diet or exercise habits recently;
- Have taken the research drug or participated in the drug clinical trial within three months before taking the research drug;
- Have a history of dysphagia or any gastrointestinal disease that affects drug absorption;
- Suffer from any diseases that increase the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers;
- Subjects who cannot tolerate standard meals (two boiled eggs, a slice of buttered bacon toast, a box of fried potato chips, a cup of whole milk);
- Abnormal ECG has clinical significance;
- Female subjects are breastfeeding or have a positive serum pregnancy result during the screening period or the test;
- Clinical laboratory tests have clinically significant abnormalities, or other clinical findings in the 12 months before screening show clinical significance for the following diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune , Mental or cardiovascular disease);
- Viral hepatitis (including hepatitis B and C), AIDS antibody, and Treponema pallidum antibody screening are positive (for those with Treponema pallidum antibody positive, additional RPR testing is required);
- Acute illness or concomitant medication from the screening stage to the study medication;
- Ingested chocolate, any caffeine-rich or xanthine-rich food or drink 48 hours before taking the study drug;
- Have taken any alcohol-containing products or a positive alcohol breath test within 48 hours before taking the study medication;
- Those who have a positive urine drug screen or have a history of drug abuse in the past five years;
- Have been exposed to metformin and/or SGLT2 inhibitor drugs such as dapagliflozin, empagliflozin, canagliflozin, and empagliflozin within 1 month before administration.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single-centre, Parallel-cohort, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Two Cohorts of Healthy Chinese Subjects in the Fed State
The trial is to assess the bioequivalence between HR20033 FDC tablet and co-administration of SHR3824 tablets and metformin XR tablets.
The primary objective is to evaluate bioequivalence of SHR3824 and Metformin in healthy Chinese subjects in the fed state.
The secondary objective is to evaluate the safety of HR20033 FDC tablet in healthy Chinese subjects.
- Conditions
- Type II Diabetes
- Being tested
- T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR, T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR
- 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.
T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XRDrug
SHR3824 5 mg + Metformin 500 mg XR In cohort 1 (low dose strength), subjects will receive treatment T1 followed by 7 days washout and then receive treatment R1+R.
T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XRDrug
SHR3824 5 mg + Metformin 500 mg XR In cohort 1 (low dose strength), subjects will receive treatment R1+R followed by 7 days washout and then receive treatment T1.
T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XRDrug
SHR3824 5 mg + Metformin 1000 mg XR In cohort 2 (high dose strength), subjects will receive treatment T2 followed by 7 days washout and then receive treatment R2+R.
T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XRDrug
SHR3824 5 mg + Metformin 1000 mg XR In cohort 2 (high dose strength), subjects will receive treatment R2+R followed by 7 days washout and then receive treatment T2.
| Study group | Role | What they receive |
|---|---|---|
| HR20033 FDC 5/500 mg | Experimental | Not described Receives: Drug: T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR |
| SHR3824 5mg + Metformin 500 mg XR | Experimental | Not described Receives: Drug: T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR |
| HR20033 FDC 5/1000 mg | Experimental | Not described Receives: Drug: T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR |
| SHR3824 5 mg + Metformin 1000 mg XR | Experimental | Not described Receives: Drug: T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR |
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 (if applicable)
Measured: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
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 posted4 Nov 2021
- Study start9 Nov 2021 (estimated)
- Primary completion3 Dec 2021 (estimated)
- Study completion10 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
- There will be two independent cohorts of subjects who will each receive two treatments (high dose strength and low dose strength), and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic assessments, with safety and tolerability. In each cohort approximately 40 healthy subjects will be randomized to receive treatment with IP to complete at least 36 evaluable subjects.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
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
- NCT05108350
- Sponsor's protocol ID
- HR20033-101
- Status last verified
- Nov 2021
- First submitted
- 3 Nov 2021
- Last updated
- 4 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 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Parallel-cohort, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Two Cohorts of Healthy Chinese Subjects in the Fed State
- ClinicalTrials.gov ID
- NCT05108350
- Acronym / sponsor ID
- HR20033-101
- Conditions
- Type II Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2021 (estimated)
- Primary completion
- 3 Dec 2021 (estimated)
- Study completion
- 10 Dec 2021 (estimated)
- First posted
- 4 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.
The trial is to assess the bioequivalence between HR20033 FDC tablet and co-administration of SHR3824 tablets and metformin XR tablets.
The primary objective is to evaluate bioequivalence of SHR3824 and Metformin in healthy Chinese subjects in the fed state.
The secondary objective is to evaluate the safety of HR20033 FDC tablet in healthy Chinese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- There will be two independent cohorts of subjects who will each receive two treatments (high dose strength and low dose strength), and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic assessments, with safety and tolerability. In each cohort approximately 40 healthy subjects will be randomized to receive treatment with IP to complete at least 36 evaluable subjects.
| Arm | Type | Receives |
|---|---|---|
| HR20033 FDC 5/500 mg | Experimental | Drug: T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR |
| SHR3824 5mg + Metformin 500 mg XR | Experimental | Drug: T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR |
| HR20033 FDC 5/1000 mg | Experimental | Drug: T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR |
| SHR3824 5 mg + Metformin 1000 mg XR | Experimental | Drug: T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sign the informed consent before the trial, and fully understand the content, process, and possible adverse reactions of the trial;
- Must be able to communicate with the investigator, understand and comply with all study requirements;
- Subject (include their fere) must have not pregnancy plan from 2 weeks prior to dose administration to 6 months after last dose administration and must use effective form of birth control;
- Male or female subjects aged 18 to 50 (including 18 and 50);
- Weigh at least 50 kg (for male) and 45 kg (for female), respectively, and have a body mass index (BMI) ≥ 18 and <28 kg/m2. BMI = weight (kg)/[height (m)]2;
Key exclusion criteria (22 listed)
- Regular smoker within 3 months prior to study drug administration, or quitting smoking less than 30 days until screening;
- History of allergy to test drugs, allergic constitution (multiple drug and food allergies);
- A history of alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); those who have abstained from alcohol have not quit for 30 days at the time of screening;
- Donate blood or lose a lot of blood (>450mL) within three months before screening;
- Take any drugs that alter liver enzyme activity 28 days before screening;
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 |
|---|---|---|
| T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XRSHR3824 5 mg + Metformin 500 mg XR In cohort 1 (low dose strength), subjects will receive treatment T1 followed by 7 days washout and then receive treatment R1+R. | Drug | HR20033 FDC 5/500 mg |
| T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XRSHR3824 5 mg + Metformin 500 mg XR In cohort 1 (low dose strength), subjects will receive treatment R1+R followed by 7 days washout and then receive treatment T1. | Drug | SHR3824 5mg + Metformin 500 mg XR |
| T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XRSHR3824 5 mg + Metformin 1000 mg XR In cohort 2 (high dose strength), subjects will receive treatment T2 followed by 7 days washout and then receive treatment R2+R. | Drug | HR20033 FDC 5/1000 mg |
| T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XRSHR3824 5 mg + Metformin 1000 mg XR In cohort 2 (high dose strength), subjects will receive treatment R2+R followed by 7 days washout and then receive treatment T2. | Drug | SHR3824 5 mg + Metformin 1000 mg XR |
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 (if applicable)
Time frame: Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
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 4 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR and T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR in people with Type II Diabetes, run by Shandong Suncadia Medicine Co., Ltd..
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 6 inclusion and 22 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 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Sheng Feng, Ph.D (13817253036, Sheng.feng@hengrui.com), or a site near the patient. 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 3 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 4 Nov 2021.