RecruitingPhase 1NCT07343245

A Phase 1 Clinical Trial to Evaluate the Safety and DDI of DW4421 and 3 NSAIDs

A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics Drug-Drug Interaction of DW4421 and 3 NSAIDs in Healthy Adult Volunteers


Sponsor

Daewon Pharmaceutical Co., Ltd.

Enrollment

150 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Drug-Drug Interaction between DW4421 and three different kinds of NSAIDs


Eligibility

Min Age: 19 YearsMax Age: 50 Years

Inclusion Criteria2

  • Healthy adult aged 19 to 50 (inclusive) years, at the time of screening.
  • Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.

Exclusion Criteria1

  • Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history

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Interventions

DRUGDW4421

QD

DRUGDW4421-N1

BID

DRUGDW4421-N2

BID

DRUGDW4421-N3

QD


Locations(1)

Chungbuk National University Hospital

Cheongju-si, South Korea

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NCT07343245


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