RecruitingPhase 1NCT06578676

To Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy Adults

A Clinical Study to Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy Adults


Sponsor

Hyundai Pharm

Enrollment

56 participants

Start Date

Jun 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate pharmacokinetic interaction and safety of co-administrated 25mg of Empagliflozin and 10/10mg Ezetimibe/Rosuvastatin in steady state in healthy volunteers.


Eligibility

Min Age: 19 Years

Inclusion Criteria3

  • Signed informed consent
  • Age: 19 and over , healthy volunteer
  • Body mass index (BMI): 18.5≤BMI≤29.9 kg/m²

Exclusion Criteria2

  • Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal
  • Clinically relevant findings(e.g. blood pressure, electrocardiogram(ECG); physical and gynecological examination, laboratory examination)

Interventions

DRUGEmpagliflozin 25 MG

PO, QD

DRUGEzetimibe/Rosuvastatin 10/10mg

PO, QD

DRUGEmpagliflozin 25 MG with Ezetimibe/Rosuvastatin 10/10mg

PO, QD


Locations(1)

Kyungpook national university hospital

Daegu, Gyeongsangbuk-do, South Korea

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NCT06578676


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