Menu
Recruiting NCT07343245

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

Phase I Interventional Healthy Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DW4421, DW4421-N1, DW4421-N2, DW4421-N3.
Who it may be relevant to
Registry conditions: Healthy Adult. Basic parameters: 19 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Drug DW4421
    QD
  • Drug DW4421-N1
    BID
  • Drug DW4421-N2
    BID
  • Drug DW4421-N3
    QD

Primary outcome measures

  • Cmax,ss [Time frame: Baseline to Day 13 or Day 15]
  • AUCτ,ss [Time frame: Baseline to Day 13 or Day 15]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

South Korea · 1 center
  • Chungbuk National University Hospital — Cheongju-si

Identifiers

NCT: NCT07343245 · DW4421-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗