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
22 participants
INTERVENTIONAL
2019-08-10
2019-12-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HSK7653 and Metformin
HSK7653
Part 1: Day 1 to Day 4, not take; Part 2: Day 6 - Take HSK7653 35 mg; HSK7653 25 mg on day 13, day 20, day 27, and day 34; Part 3: Day 41 - Take HSK7653 25 mg
Metformin
Part 1: Day 1 to Day 4, 1000mg BID; Part 2: Not take; Part 3: Day 38- day 47, 1000mg BID
Interventions
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HSK7653
Part 1: Day 1 to Day 4, not take; Part 2: Day 6 - Take HSK7653 35 mg; HSK7653 25 mg on day 13, day 20, day 27, and day 34; Part 3: Day 41 - Take HSK7653 25 mg
Metformin
Part 1: Day 1 to Day 4, 1000mg BID; Part 2: Not take; Part 3: Day 38- day 47, 1000mg BID
Eligibility Criteria
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Inclusion Criteria
* BMI ≥18 and BMI ≤ 28 kg/m2 (Body Mass Index)
* Able to understand the procedures of the study, and provide written informed consent and willing to comply with the study protocol procedures.
Exclusion Criteria
* Fasting blood glucose \<3.9mmol/L or ≥6.1mmol/L;
* Has a condition affecting the absorption, distribution, metabolism, and excretion of the drug;
* Has a positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), Treponema pallidum antibody (TP-Ab) or human immunodeficiency virus (HIV);
* Treatment with an investigational drug within 3 months;
18 Years
60 Years
ALL
Yes
Sponsors
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Haisco Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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HSK7653-102
Identifier Type: -
Identifier Source: org_study_id
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