Status:
RECRUITING
To Evaluate the Safety and Pharmacokinetic Interaction Between HODO-22251 and HODO-22252 in Healthy Adults
Lead Sponsor:
Hyundai Pharm
Collaborating Sponsors:
Kyungpook National University Hospital
Conditions:
Type 2 Diabetes
Dyslipidemias
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief 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.
Detailed Description
This trial is a phase 1 study to evaluate pharmacokinetic interaction and safety of co-administrated 25mg of Empagliflozin and 10/10mg of Ezetimibe/Rosuvastatin in steady state in healthy volunteers. ...
Eligibility Criteria
Inclusion
- Signed informed consent
- Age: 19 and over , healthy volunteer
- Body mass index (BMI): 18.5≤BMI≤29.9 kg/m²
Exclusion
- 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)
Key Trial Info
Start Date :
June 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06578676
Start Date
June 20 2024
End Date
November 30 2024
Last Update
August 29 2024
Active Locations (1)
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1
Kyungpook national university hospital
Daegu, Gyeongsangbuk-do, South Korea