A Study to Assess the Bioequivalence of Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Healthy Chinese Subjects
Primary Purpose
Type II Diabetes
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR
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
T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR
Sponsored by
About this trial
This is an interventional treatment trial for Type II Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
HR20033 FDC 5/500 mg
SHR3824 5mg + Metformin 500 mg XR
HR20033 FDC 5/1000 mg
SHR3824 5 mg + Metformin 1000 mg XR
Arm Description
Outcomes
Primary Outcome Measures
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Cmax
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: AUC0-t
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: AUC0-inf (if applicable)
Secondary Outcome Measures
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Tmax
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Vz/F
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: CL/F
Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: t1/2
Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Tmax
Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Ctrough
Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Racc etc
The incidence and severity of adverse events/serious adverse events
Full Information
NCT ID
NCT05108350
First Posted
November 3, 2021
Last Updated
November 3, 2021
Sponsor
Shandong Suncadia Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05108350
Brief Title
A Study to Assess the Bioequivalence of Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Healthy Chinese Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 9, 2021 (Anticipated)
Primary Completion Date
December 3, 2021 (Anticipated)
Study Completion Date
December 10, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shandong Suncadia Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
The secondary objective is to evaluate the safety of HR20033 FDC tablet in healthy Chinese subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HR20033 FDC 5/500 mg
Arm Type
Experimental
Arm Title
SHR3824 5mg + Metformin 500 mg XR
Arm Type
Experimental
Arm Title
HR20033 FDC 5/1000 mg
Arm Type
Experimental
Arm Title
SHR3824 5 mg + Metformin 1000 mg XR
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng Feng, Ph.D
Phone
13817253036
Email
Sheng.feng@hengrui.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Rao, M.M
Phone
17612186457
Email
jing.rao@hengrui.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study to Assess the Bioequivalence of Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Healthy Chinese Subjects
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