PK and Safety Comparison of DWJ445 and DWC202506 in Healthy Volunteers

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence After Administration of "DWJ1445" and "DWC202506" in Healthy Adults

A bioequivalence study comparing DWJ1445 and DWC202506 in healthy adults

This is an open-label, randomized, single-dose, 2-treatment, 2-period, crossover, bioequivalence study conducted under fasting conditions to compare and evaluate the pharmacokinetics and safety of DWJ1445 and DWC202506 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.

Inclusion Criteria:

• Subjects with a body mass index (BMI) between 18 and 30 kg/m²
• Subjects without any clinically significant congenital or chronic disease, and with no pathological findings based on medical examination
• Subjects who agree to use a medically acceptable method of contraception

Exclusion Criteria:

• Subjects who have participated in a bioequivalence or other clinical trial and received an investigational product within 6 months prior to the first dose
• Subjects with a history of gastrointestinal surgery that may affect drug absorption
• Subjects with a clinically significant history of psychiatric illness Female subjects who are pregnant, suspected of being pregnant, or currently breastfeeding