A Study to Evaluate the DDI of HSK7653 With Metformin
Study Details
Study Description
Brief Summary
This is a Phase 1, single center, open-label, single arm, drug-drug interaction study of HSK7653 and metformin in Healthy Subjects.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: HSK7653 and Metformin
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Drug: 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
Drug: Metformin
Part 1: Day 1 to Day 4, 1000mg BID; Part 2: Not take; Part 3: Day 38- day 47, 1000mg BID
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Outcome Measures
Primary Outcome Measures
- The primary pharmacokinetics parameter of Cmax To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects. [Day4, day 27 and day 41]
- The primary pharmacokinetics parameter of AUC To assess the potential pharmacokinetic interaction between HSK7653 and metformin in health subjects. [Day4, day 27 and day 41]
Secondary Outcome Measures
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [First dose of study drug up to 62 days after last dose of study drug]
- Pharmacodynamic responses of glucose, insulin and C-peptide will be evaluated [Day 41]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 and Age ≤60 years
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BMI ≥18 and BMI ≤ 28 kg/m2 (Body Mass Index)
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Able to understand the procedures of the study, and provide written informed consent and willing to comply with the study protocol procedures.
Exclusion Criteria:
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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;
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Fasting blood glucose <3.9mmol/L or ≥6.1mmol/L;
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Has a condition affecting the absorption, distribution, metabolism, and excretion of the drug;
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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);
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Treatment with an investigational drug within 3 months;
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Other protocol-defined exclusion criteria.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Peking University Third Hospital | Beijing | Beijing | China | 100191 |
Sponsors and Collaborators
- Haisco Pharmaceutical Group Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSK7653-102