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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07343245

Enrollment

150

Registered

2026-01-15

Start date

2025-12-01

Completion date

2026-06-17

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult

Brief summary

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

Interventions

DRUGDW4421

DRUGDW4421-N1

BID

DRUGDW4421-N2

BID

DRUGDW4421-N3

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Cmax,ss	Baseline to Day 13 or Day 15
AUCτ,ss	Baseline to Day 13 or Day 15

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026