Study of the Bioequivalence and Food Effects of HRX0701 Tablets in Healthy Subjects
NCT ID: NCT05415644
Last Updated: 2022-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
78 participants
INTERVENTIONAL
2022-07-05
2022-08-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Bioequivalence study part
hrx0701 tablets、Metformin hydrochloride tablets、Retagliptin phosphate tablets
High-specification group: subject preparation: HRX0701 (50 mg/1000 mg) 1 tablet (to be taken after a meal); Reference preparation: 1 tablet of retagliptin phosphate (50 mg), 2 tablets of metformin hydrochloride (Glucophage®) (500 mg), taken twice after meals.
Low Specification Group:
Preparation: HRX0701 (50 mg/850 mg) 1 tablet (taken after a meal); Reference: 1 tablet of retagliptin phosphate (50 mg), 1 tablet of metformin hydrochloride (Glucophage®) (850 mg), taken twice after meals.
Food impact study part
hrx0701 tablets
High specification group HRX0701 (FDC) tablets (50 mg / 1000 mg) for a total of 2 tablets (take 1 tablet after meals or on an empty stomach).
Low-spec group HRX0701 (FDC) tablets (50 mg / 850 mg) for a total of 2 tablets (take 1 tablet after meals or on an empty stomach).
Interventions
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hrx0701 tablets、Metformin hydrochloride tablets、Retagliptin phosphate tablets
High-specification group: subject preparation: HRX0701 (50 mg/1000 mg) 1 tablet (to be taken after a meal); Reference preparation: 1 tablet of retagliptin phosphate (50 mg), 2 tablets of metformin hydrochloride (Glucophage®) (500 mg), taken twice after meals.
Low Specification Group:
Preparation: HRX0701 (50 mg/850 mg) 1 tablet (taken after a meal); Reference: 1 tablet of retagliptin phosphate (50 mg), 1 tablet of metformin hydrochloride (Glucophage®) (850 mg), taken twice after meals.
hrx0701 tablets
High specification group HRX0701 (FDC) tablets (50 mg / 1000 mg) for a total of 2 tablets (take 1 tablet after meals or on an empty stomach).
Low-spec group HRX0701 (FDC) tablets (50 mg / 850 mg) for a total of 2 tablets (take 1 tablet after meals or on an empty stomach).
Eligibility Criteria
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Inclusion Criteria
2. Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, and body mass index (BMI): 19\~26 kg/m2 (including both ends).
3. Based on medical history, comprehensive physical examination, laboratory tests, 12-lead ECG, chest x-ray, vital signs, etc., the researchers determined that the subjects met the health criteria.
4. Voluntarily sign an informed consent form prior to the commencement of activities related to this trial, be able to understand the procedures and methods of this trial, and be willing to complete this trial in strict compliance with the clinical trial protocol.
Exclusion Criteria
2. People with allergies, including those who are explicitly allergic to the research drug or any ingredient in the research drug, allergic to any food ingredients or have special requirements for diet, and cannot comply with the unified diet.
3. Those who have undergone any surgery within 3 months before screening, or who have not recovered after surgery, or who may have surgery or hospitalization plans during the estimated trial period.
4. Have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or dietary supplements within 2 weeks before the screening period;
5. Those who have consumed grapefruit or fruit juice products within 2 days before administration, any food or beverage containing caffeine (such as coffee, tea, chocolate, cola or other carbonated drinks containing caffeine, etc.), xanthine foods or alcohol.
6. The researcher determines that the subject has a medical condition that affects the absorption, distribution, metabolism and excretion of the drug or can reduce compliance or the researcher deems inappropriate.
7. Screening those who have participated in clinical trials of any drug or medical device within 3 months before screening.
8. Those who donated blood (or lost blood) within 3 months before screening and donated blood (or lost blood) ≥ 400 mL, or received blood transfusions.
9. Those who plan to receive live (attenuated) vaccines during the trial.
10. Have a birth plan at the end of the screening to follow-up period, or refuse to use medically approved contraception.
11. Smokers (average of 5 cigarettes or more per day).
12. An average daily intake of more than 25 g of alcohol in the 1 month prior to screening (e.g., 750 mL of beer, 250 mL of wine, or 50 mL of low-grade liquor);
13. Drug abusers or drug urine screening test positive.
14. Positive for hepatitis B surface antigen (HBsAg) within 1 month before screening or screening period, or positive for anti-hepatitis C virus (HCV), or positive for human immunodeficiency virus (HIV), or positive for syphilis antibody.
15. 12-lead electrocardiogram (ECG) shows abnormalities and is of clinical significance.
16. There are any abnormal laboratory test values that are clinically significant by the researchers; (Note: For abnormal laboratory tests with clinical significance, if there is a clear and reasonable reason, the retest can be retested within one week, and the retest results can be used to determine whether the subject meets the conditions).
17. Subjects may not be able to complete this study for other reasons or those whom the researchers believe should not be included.
18 Years
45 Years
ALL
Yes
Sponsors
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Shandong Suncadia Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Xiangya Third Hospital
Changsha, Hunan, China
Countries
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Other Identifiers
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HRX0701-101
Identifier Type: -
Identifier Source: org_study_id