ClinicalTrials.Veeva

Menu

A Study to Evaluate the DDI of HSK7653 With Metformin

Haisco Pharmaceutical Group logo

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

NCT06084156
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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

HSK7653 and Metformin
Experimental group
Treatment:
Drug: Metformin
Drug: HSK7653

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems