Type 2 DiabetesPhase 1NCT05692934
A HR20031 FE Study on Healthy Subjects
A Phase 1 study testing HR20031 FDC in people with Type 2 Diabetes, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to assess the effect of food on the single-dose PK of SHR3824, SP2086 and metformin in the HR20031 FDC tablets in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- HR20031 FDC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2023to 11 Mar 2023
- 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. Must be able to communicate with the investigator, understand and 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;
- Fasting plasma glucose in the range of 3.9-6.1 mmol/L.
- According to medical history, physical examination, laboratory tests, 12-lead electrocardiogram, chest X-ray, and vital signs, the investigators determined that the subjects met the health criteria.
Who cannot join
- Subject (include their fere) have pregnancy plan from 2 weeks prior to dose administration to follow-up period and refuse to use effective form of birth control;
- Those who have a positive urine drug screen or have a history of drug abuse;
- Excessive smoking (≥ 5 cigarettes/day);
- History of alcoholism or regular alcohol consumption within 1 month before screening, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer with 5% alcohol or 45 mL of spirits with 40% alcohol or 150 mL of wine with 12% alcohol)
- Subjects who took any beverage or food containing grapefruit, xanthine, caffeine, or alcohol within 48 hours before dosing or other factors which affect drug absorption, distribution, metabolism, excretion, etc
- Subjects with medical conditions that may affect the absorption, distribution, metabolism, and excretion of the drug or impair adherence to the drug as judged by the investigator or deemed inappropriate by the investigator;
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- Subjects with poor compliance or other reasons deemed by the investigator to be unfit for the trial;
- Viral hepatitis (including hepatitis B and C), AIDS antibody, and Treponema pallidum antibody screening are positive;
- Clinical laboratory tests have clinically significant abnormalities;
- Abnormal ECG has clinical significance;
- Other clinical findings 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);
- History of allergy to test drugs, allergic constitution (multiple drug and food allergies);
- Subjects who undergone any surgery within 3 months before screening, have not recovered from surgery, or have plans to surgery or hospitalization during the trial;
- Donate blood or lose a lot of blood (>400mL) within three months before screening;
- Subjects with a history of severe hypoglycaemia;
- Subjects with a history of recurrent urinary tract infection or/and genital fungal infection;
- Participated in the drug clinical trial and have taken drug or within three months before taking the research drug;
- Take any prescription drugs, any vitamin products or herbal medicines within 14 days before screening or take any over-the-counter drugs within 1 month before screening;
- Exposure to metformin and/or SGLT2 inhibitors such as dapagliflozin, empagliflozin, canagliflozin, ertugliflozin, and DPP-IV inhibitors such as sitagliptin, saxagliptin, linagliptin, or vildagliptin within 1 month before screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Assess the Effect of Food on HR20031 Tablet in Healthy Subjects
The purpose of this study is to assess the effect of food on the single-dose PK of SHR3824, SP2086 and metformin in the HR20031 FDC tablets in healthy subjects.
- Conditions
- Type 2 Diabetes
- Being tested
- HR20031 FDC
- 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.
HR20031 FDCDrug
Subjects will receive treatment HR20031 FDC 10/100/1000 mg in the fast state followed by 7 days washout ，then receive treatment HR20031 FDC 10/100/1000 mg in the fed state .
HR20031 FDCDrug
Subjects will receive treatment HR20031 FDC 10/100/1000 mg in the fed state followed by 7 days washout ，then receive treatment HR20031 FDC 10/100/1000 mg in the fast state.
HR20031 FDCDrug
Subjects will receive treatment S HR20031 FDC 5/50/750 mg*2 in the fast state followed by 7 days washout ，then receive treatment HR20031 FDC 5/50/750 mg*2 in the fed state.
HR20031 FDCDrug
Subjects will receive treatment HR20031 FDC 5/50/750 mg*2 in the fed state followed by 7 days washout ，then receive treatment HR20031 FDC 5/50/750 mg*2 in the fast state.
| Study group | Role | What they receive |
|---|---|---|
| HR20031 FDC 10/100/1000 mg in the fast state | Experimental | Not described Receives: Drug: HR20031 FDC |
| HR20031 FDC 10/100/1000 mg in the fed state | Experimental | Not described Receives: Drug: HR20031 FDC |
| HR20031 FDC 5/50/750 mg*2 in the fast state | Experimental | Not described Receives: Drug: HR20031 FDC |
| HR20031 FDC 5/50/750 mg*2 in the fed state | Experimental | Not described Receives: Drug: HR20031 FDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameters of SHR3824 in the fast and fed state: Cmax
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: Cmax
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: Cmax
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 in the fast and fed state: AUC0-t
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: AUC0-t
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: AUC0-t
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 in the fast and fed state: AUC0-inf (if applicable)
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: AUC0-inf (if applicable)
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: AUC0-inf (if applicable)
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Secondary outcomes (20)
Pharmacokinetics parameters of SP2086A in the fast and fed state: Cmax
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086A in the fast and fed state: AUC0-t
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086A in the fast and fed state: AUC0-inf (if applicable)
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 in the fast and fed state: Tmax
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: Tmax
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086A in the fast and fed state: Tmax
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: Tmax
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 in the fast and fed state: Vz/F
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: Vz/F
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086A in the fast and fed state: Vz/F
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: Vz/F
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 in the fast and fed state: CL/F
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: CL/F
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086A in the fast and fed state: CL/F
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: CL/F
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 in the fast and fed state: t1/2
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: t1/2
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086A in the fast and fed state: t1/2
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: t1/2
Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
The incidence and severity of adverse events/serious adverse events
Measured: From signed the informed consent form to Day 15 safety visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start31 Jan 2023
- Primary completion11 Mar 2023
- Study completion11 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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 32 evaluable subjects.
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT05692934
- Sponsor's protocol ID
- HR20031-102
- Status last verified
- Apr 2023
- First submitted
- 28 Dec 2022
- Last updated
- 4 Apr 2023
- 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 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Effect of Food on HR20031 Tablet in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05692934
- Acronym / sponsor ID
- HR20031-102
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 11 Mar 2023 (actual)
- Study completion
- 11 Mar 2023 (actual)
- First posted
- 20 Jan 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.
The purpose of this study is to assess the effect of food on the single-dose PK of SHR3824, SP2086 and metformin in the HR20031 FDC tablets in healthy 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 32 evaluable subjects.
| Arm | Type | Receives |
|---|---|---|
| HR20031 FDC 10/100/1000 mg in the fast state | Experimental | Drug: HR20031 FDC |
| HR20031 FDC 10/100/1000 mg in the fed state | Experimental | Drug: HR20031 FDC |
| HR20031 FDC 5/50/750 mg*2 in the fast state | Experimental | Drug: HR20031 FDC |
| HR20031 FDC 5/50/750 mg*2 in the fed state | Experimental | Drug: HR20031 FDC |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 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;
- 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;
- Fasting plasma glucose in the range of 3.9-6.1 mmol/L.
- According to medical history, physical examination, laboratory tests, 12-lead electrocardiogram, chest X-ray, and vital signs, the investigators determined that the subjects met the health criteria.
Key exclusion criteria (19 listed)
- Subject (include their fere) have pregnancy plan from 2 weeks prior to dose administration to follow-up period and refuse to use effective form of birth control;
- Those who have a positive urine drug screen or have a history of drug abuse;
- Excessive smoking (≥ 5 cigarettes/day);
- History of alcoholism or regular alcohol consumption within 1 month before screening, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer with 5% alcohol or 45 mL of spirits with 40% alcohol or 150 mL of wine with 12% alcohol)
- Subjects who took any beverage or food containing grapefruit, xanthine, caffeine, or alcohol within 48 hours before dosing or other factors which affect drug absorption, distribution, metabolism, excretion, etc
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 |
|---|---|---|
| HR20031 FDCSubjects will receive treatment HR20031 FDC 10/100/1000 mg in the fast state followed by 7 days washout ，then receive treatment HR20031 FDC 10/100/1000 mg in the fed state . | Drug | HR20031 FDC 10/100/1000 mg in the fast state |
| HR20031 FDCSubjects will receive treatment HR20031 FDC 10/100/1000 mg in the fed state followed by 7 days washout ，then receive treatment HR20031 FDC 10/100/1000 mg in the fast state. | Drug | HR20031 FDC 10/100/1000 mg in the fed state |
| HR20031 FDCSubjects will receive treatment S HR20031 FDC 5/50/750 mg*2 in the fast state followed by 7 days washout ，then receive treatment HR20031 FDC 5/50/750 mg*2 in the fed state. | Drug | HR20031 FDC 5/50/750 mg*2 in the fast state |
| HR20031 FDCSubjects will receive treatment HR20031 FDC 5/50/750 mg*2 in the fed state followed by 7 days washout ，then receive treatment HR20031 FDC 5/50/750 mg*2 in the fast state. | Drug | HR20031 FDC 5/50/750 mg*2 in the fed state |
Primary outcome
Pharmacokinetics parameters of SHR3824 in the fast and fed state: Cmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: Cmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: Cmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 in the fast and fed state: AUC0-t
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: AUC0-t
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: AUC0-t
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 in the fast and fed state: AUC0-inf (if applicable)
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: AUC0-inf (if applicable)
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: AUC0-inf (if applicable)
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
20 secondary outcomes
Pharmacokinetics parameters of SP2086A in the fast and fed state: Cmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086A in the fast and fed state: AUC0-t
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086A in the fast and fed state: AUC0-inf (if applicable)
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 in the fast and fed state: Tmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: Tmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086A in the fast and fed state: Tmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: Tmax
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 in the fast and fed state: Vz/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: Vz/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086A in the fast and fed state: Vz/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: Vz/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 in the fast and fed state: CL/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: CL/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086A in the fast and fed state: CL/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: CL/F
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SHR3824 in the fast and fed state: t1/2
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086 in the fast and fed state: t1/2
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of SP2086A in the fast and fed state: t1/2
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
Pharmacokinetics parameters of Metformin in the fast and fed state: t1/2
Time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8
The incidence and severity of adverse events/serious adverse events
Time frame: From signed the informed consent form to Day 15 safety visit
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 4 Apr 2023.
- 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 HR20031 FDC in people with Type 2 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 5 inclusion and 19 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 4 Apr 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?
Pharmacokinetics parameters of SHR3824 in the fast and fed state: Cmax (time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8). The study lists 9 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 Apr 2023.