Phase 1 Study to Assess the Safety and Drug Interaction of DW4421 and Three NSAIDs in Healthy Adults Aged 19 to 50

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.

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