RecruitingPhase 1NCT07144176

PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers

An Open-label, Randomized, Fasting, Single-dose, Two-treatment, Two-period, Crossover, Phase 1 Clinical Trial to Compare and Evaluate the Pharmacokinetics and Safety of "DWJ1511" and "DWC202501" in Healthy Adult Volunteers

Sponsor

Daewoong Pharmaceutical Co. LTD.

Enrollment

60 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Subjects

Summary

PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers

Eligibility

Min Age: 19 YearsMax Age: 64 Years

Inclusion Criteria2

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 Criteria3

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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