PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers

This is an open-label, randomized, single-dose, two-treatment, two-period, crossover, phase 1 clinical trial conducted under fasting conditions to compare and evaluate the pharmacokinetics (PK) and safety of DWJ1511 and DWC202501. in healthy adult volunteers. Participants will receive both study drugs in separate periods, with a washout interval between administrations. The study aims to assess PK parameters and monitor safety through clinical evaluations and laboratory tests.

• DWJ1511 (Drug): Test drug: DWJ1511
• DWC202501 (Drug): Comparator: DWC202501

Primary outcomes

• Area under the plasma drug concentration-time curve [AUCt] [0-12 Hours]: Area under the plasma drug concentration-time curve \[AUCt\] of DWJ1511 and DWC202501
• Maximum plasma concentration [Cmax] [0-12 Hours]: Maximum plasma concentration \[Cmax\] of DWJ1511 and DWC202501

Secondary outcomes

• Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] [0-12 Hours]: Area under the plasma drug concentration-time curve from time 0 to infinity \[AUCinf\] of DWJ1511 and DWC202501

Sex: All, ages: 19 Years to 64 Years, accepts healthy volunteers

Inclusion Criteria:

* Male or female participants aged ≥19 years and <65 years at the time of screening
* Body mass index (BMI) between 18 and 30 kg/m² (BMI = weight \[kg\] / height \[m\]²)

Exclusion Criteria:

* Subjects who have participated in a bioequivalence study or any other clinical trial and have received an investigational product within 6 months prior to the first administration.
* Subjects who have donated whole blood within 8 weeks prior to the first administration, donated blood components within 2 weeks prior to the first administration, or received a blood transfusion within 4 weeks prior to the first administration.
* Subjects with a history of gastrointestinal surgery that may affect drug absorption (appendectomy and hernia repair are not exclusionary).