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Recruiting Phase 1 NCT07144176

PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers

Trial Parameters

Condition Healthy Subjects
Sponsor Daewoong Pharmaceutical Co. LTD.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 60
Sex ALL
Min Age 19 Years
Max Age 64 Years
Start Date 2025-09
Completion 2025-09
Interventions
DWJ1511DWC202501

Brief Summary

PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers

Eligibility Criteria

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).

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