A Study to Evaluate the DDI of HSK7653 With Metformin

Haisco Pharmaceutical Group

Status and phase

Completed

Phase 1

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Metformin

Drug: HSK7653

Study type

Interventional

Funder types

Industry

Identifiers

HSK7653-102

Details and patient eligibility

About

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

Enrollment

22 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.