A HR20031 BE Study on Healthy Subjects

Last updated: April 6, 2023
Sponsor: Shandong Suncadia Medicine Co., Ltd.
Overall Status: Completed

Phase

1

Condition

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT05682495
HR20031-101
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to assess the bioequivalence between HR20031 FDC tablet and co-administration of SHR3824 tablets, SP2086 tablets and metformin XR tablets.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Sign the informed consent before the trial, and fully understand the content, processand possible adverse reactions of the trial. Must be able to communicate with theinvestigator, understand and 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 bodymass index (BMI) ≥ 19 and ≤28 kg/m2. BMI = weight (kg)/[height (m)]2;
  4. Fasting plasma glucose in the range of 3.9-6.1 mmol/L.

Exclusion

Exclusion Criteria:

  1. Subject (include their fere) have pregnancy plan from 2 weeks prior to doseadministration to follow-up period and refuse to use effective form of birth control;
  2. Those who have a positive urine drug screen or have a history of drug abuse;
  3. Excessive smoking (≥ 5 cigarettes/day);
  4. 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)
  5. Subjects who took any beverage or food containing grapefruit, xanthine, caffeine, oralcohol within 48 hours before dosing or other factors which affect drug absorption,distribution, metabolism, excretion, etc
  6. 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 theinvestigator or deemed inappropriate by the investigator;
  7. Viral hepatitis (including hepatitis B and C), AIDS antibody, and Treponema pallidumantibody screening are positive;
  8. Clinical laboratory tests have clinically significant abnormalities;
  9. Abnormal ECG has clinical significance;
  10. Other clinical findings before screening show clinical significance for the followingdiseases (including but not limited to gastrointestinal tract, kidney, liver, nerve,blood, endocrine, tumor, lung, immune, Mental or cardiovascular disease);
  11. History of allergy to test drugs, allergic constitution (multiple drug and foodallergies);
  12. Subjects who undergone any surgery within 3 months before screening, have notrecovered from surgery, or have plans to surgery or hospitalization during the trial;
  13. Donate blood or lose a lot of blood (>400mL) within three months before screening;
  14. Subjects with a history of severe hypoglycaemia;
  15. Subjects with a history of recurrent urinary tract infection or/and genital fungalinfection;
  16. Participated in the drug clinical trial and have taken drug or within three monthsbefore taking the research drug;
  17. Take any prescription drugs, any vitamin products or herbal medicines within 14 daysbefore screening or take any over-the-counter drugs within 1 month before screening;
  18. 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.

Study Design

Total Participants: 96
Study Start date:
January 31, 2023
Estimated Completion Date:
April 04, 2023

Connect with a study center

  • Jinan Central Hospital

    Jinan, Shandong 250013
    China

    Site Not Available

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