A Study to Evaluate the DDI of HSK7653 With Metformin

• Status: Completed
• Trial end date: 2019-12-09
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, single center, open-label, single arm, drug-drug interaction study of HSK7653 and metformin in Healthy Subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Haisco Pharmaceutical Group Co., Ltd.
• Treatments: Metformin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.