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A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics Drug-Drug Interaction of DW4421 and 3 NSAIDs in Healthy Adult Volunteers
Led by Daewon Pharmaceutical Co., Ltd. · Updated on 2026-01-15
150
Participants Needed
1
Research Sites
16 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates the safety and drug-drug interaction between DW4421 and three different nonsteroidal anti-inflammatory drugs (NSAIDs) in healthy adult volunteers. The study is a Phase 1 clinical trial designed to assess how these drugs interact in the body, focusing on their pharmacokinetics, which helps understand the drug levels and behavior over time. Participants will receive different forms of the investigational drug DW4421, administered once daily or twice daily depending on the variant (DW4421, DW4421-N1, DW4421-N2, DW4421-N3). The study is randomized and includes several cohorts to evaluate these combinations carefully. Each participant will follow specific dosing schedules during the trial. During the trial, researchers will monitor participants closely through various assessments including measuring drug concentration peaks (Cmax) and overall exposure (AUC) from baseline to study days 13 or 15. Healthy volunteers aged 19 to 50 will be observed for any safety concerns or changes in how the drugs work together. The total study participation lasts from the start until the final assessments around day 15, with continuous monitoring of drug interactions and safety.
CONDITIONS
Brief Title
A Phase 1 Clinical Trial to Evaluate the Safety and DDI of DW4421 and 3 NSAIDs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adult aged 19 to 50 (inclusive) years at the time of screening
- Weight between 50 kg and 90 kg
- Body mass index (BMI) between 18 and 27 kg/m2 (inclusive) at screening visit
You will not qualify if you...
- History or presence of clinically significant diseases affecting liver, kidney, nervous system, respiratory, endocrine, blood, cancer, cardiovascular, urinary, or mental health
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 15 days
Participants receive study drugs DW4421 and NSAIDs according to their assigned cohort to evaluate safety and drug interactions.
Multiple visits during treatment period
Trial Site Locations
Total: 1 location
1
Chungbuk National University Hospital
Cheongju-si, South Korea
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
6
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