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

Sponsor
Hyundai Pharm
Study ID
NCT06578676
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 20, 2024
Status verified
Aug 2024
Primary completion
Sep 2, 2024
Completion
Nov 30, 2024

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Empagliflozin 25mg
    * Period 1: Empagliflozin (QD, 5d) * wash-out: 7d * Period 2: Ezetimibe/Rosuvastatin (QD, 2d) and Empagliflozin and Ezetimibe/Rosuvastatin (QD, 5d)
  • Experimental: Rosuvastatin/Ezetimibe 10/10mg
    * Period 1: Ezetimibe/Rosuvastatin (QD, 7d) * wash-out: 14d * Period 2: Ezetimibe/Rosuvastatin (QD, 2d) and Empagliflozin and Ezetimibe/Rosuvastatin (QD, 5d)

Primary Outcome Measure

Cmax,ss of Empagliflozin, Total Ezetimibe and Rosuvastatin [ Time Frame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48hours of after administration ]

Central Contacts

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