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

January 6, 2026 updated by: Daewon Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Cheongju-si, South Korea
        • Recruiting
        • Chungbuk National University Hospital
        • Contact:
          • Chungbuk National University Hospital
          • Phone Number: +82-43-269-6771
          • Email: cbnuhirb@naver.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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 Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1, A
Drug: DW4421
QD
Drug: DW4421-N1
BID
Experimental: Cohort 1, B
Drug: DW4421
QD
Drug: DW4421-N1
BID
Experimental: Cohort 2, C
Drug: DW4421
QD
Drug: DW4421-N2
BID
Experimental: Cohort 2, D
Drug: DW4421
QD
Drug: DW4421-N2
BID
Experimental: Cohort 3, E
Drug: DW4421
QD
Drug: DW4421-N3
QD
Experimental: Cohort 3, F
Drug: DW4421
QD
Drug: DW4421-N3
QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax,ss
Time Frame: Baseline to Day 13 or Day 15
Baseline to Day 13 or Day 15
AUCτ,ss
Time Frame: Baseline to Day 13 or Day 15
Baseline to Day 13 or Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewon Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

February 22, 2026

Study Completion (Estimated)

June 17, 2026

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • DW4421-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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