Status:
COMPLETED
A Study to Evaluate the DDI of HSK7653 With Metformin
Lead Sponsor:
Haisco Pharmaceutical Group Co., Ltd.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, single center, open-label, single arm, drug-drug interaction study of HSK7653 and metformin in Healthy Subjects.
Eligibility Criteria
Inclusion
- Age ≥18 and Age ≤60 years
- 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
- Any finding of the medical examination (physical examination, laboratory examination, 12-ECG, abdominal B-ultrasonography, etc) deviating from normal and of clinical relevance during screening;
- 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;
- Other protocol-defined exclusion criteria.
Key Trial Info
Start Date :
August 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06084156
Start Date
August 10 2019
End Date
December 9 2019
Last Update
October 16 2023
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191