Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05120219
Other study ID # HR20033-102
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date October 13, 2021
Est. completion date December 20, 2021

Study information

Verified date November 2021
Source Shandong Suncadia Medicine Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 28
Est. completion date December 20, 2021
Est. primary completion date November 17, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: 1. 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; 2. Male or female subjects aged 18 to 45 (including 18 and 45). 3. 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; 4. 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. Exclusion Criteria: 1. 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; 2. Drug abusers or those who test positive for drug abuse screening; 3. 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; 4. 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; 5. 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; 6. 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; 7. 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; 8. There are any abnormal laboratory test values that are judged by the investigator to be clinically meaningful; 9. The 12-lead electrocardiogram (ECG) is abnormal and has clinical significance; 10. Female subjects are breastfeeding or have a positive serum pregnancy result during the screening period or the test; 11. 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; 12. 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; 13. 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; 14. Those who donated blood (or blood loss) within 3 months before screening and donated blood (or blood loss) =400 mL, or received blood transfusion; 15. Those who have participated in clinical trials of any drug or medical device within 3 months before screening; 16. Have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or dietary supplements within 2 weeks before the screening period; 17. Have taken metformin and/or SGLT2 inhibitor drugs such as dapagliflozin, empagliflozin, canagliflozin, and empagliflozin within 1 month before administration.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
FDC tablet
single HR20033 FDC tablet fed, take orally on an empty stomach and then after meals
FDC tablet
single HR20033 FDC tablet fasted, take orally after meals and then on an empty stomach
FDC tablet
single and multiple doses of HR20033 FDC tablet

Locations

Country Name City State
China The Second Affiliated Hospital of Anhui Medical University Hefei Anhui

Sponsors (1)

Lead Sponsor Collaborator
Shandong Suncadia Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Cmax Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Primary Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: AUC0-t Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Primary Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: AUC0-inf Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Primary Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Cmax 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
Primary Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: AUC0-inf 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
Primary Pharmacokinetics parameters of SHR3824 and Metformin after multiple dose: Cmax,ss 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
Primary Pharmacokinetics parameters of SHR3824 and Metformin after multiple dose: AUCss 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 Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Tmax Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Secondary Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Vz/F Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Secondary Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: CL/F Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Secondary Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: t1/2 Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Secondary Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Tmax Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Secondary Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Ctrough Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Secondary Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Racc etc Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
Secondary The incidence and severity of adverse events/serious adverse events Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8
See also
  Status Clinical Trial Phase
Withdrawn NCT04569214 - The Efficacy and Safety of PAZ320 on PPG and Insulin Blood Levels in Type II Diabetic Patients Phase 2
Completed NCT02127762 - The Effect of Mindfulness Based Stress Reduction in Patients With Painful Diabetic Peripheral Neuropathy N/A
Completed NCT01698528 - Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration N/A
Completed NCT00985114 - Safety and Efficacy Study of EndoBarrier in Subjects With Type II Diabetes and Obesity N/A
Completed NCT04893135 - Impact of the Rapid Normalization of Chronic Hyperglycemia and the Practice of Moderate Physical Activity on the "Receptor Activator of Nuclear Factor-kappa B Ligand / Osteoprotégérine (RANKL / OPG) System in Patients Living With Type II Diabetes N/A
Not yet recruiting NCT05108350 - A Study to Assess the Bioequivalence of Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Healthy Chinese Subjects Phase 1
Completed NCT02586129 - Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II Diabetes Phase 3
Completed NCT02914743 - Providing Preventive Periodontal Treatment to Hospitalized Patients With Diabetes N/A
Completed NCT04540016 - Mass Balance and Biotransformation of [14C]HSK7653 in Human Phase 1
Completed NCT02429258 - Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin Phase 4
Completed NCT01055223 - Fracture Risk With Thiazolidinediones N/A
Terminated NCT02365233 - Fatty Liver Study in Patients With Type II Diabetes Phase 4
Completed NCT05878587 - Burger Allen Exercises in Knee OA With Type II Diabetes N/A
Completed NCT04768673 - A Study to Investigate the PK and Safety of CKD-393 Phase 1
Not yet recruiting NCT05028140 - Efficacy and Safety of Piemonte Association in the Treatment of Type II Diabetes Mellitus Phase 3
Terminated NCT01804777 - Epithelial Sodium Channel (ENaC) as a Novel Mechanism for Hypertension and Volume Expansion in Type 2 Diabetes Early Phase 1
Completed NCT01619332 - Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763 Phase 1/Phase 2
Active, not recruiting NCT06387433 - Effectiveness of an mHealth Mobile App N/A
Completed NCT01881074 - Periodontal Treatment Response in Type II Diabetic Patients
Not yet recruiting NCT01591525 - Diabetes Mellitus Community Based Screening in Minority Populations N/A