Recruiting NCT07343245
A Phase 1 Clinical Trial to Evaluate the Safety and DDI of DW4421 and 3 NSAIDs
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 →
Unsure about the terms? Read our patient guide →
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