NCT07144176

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 64 Years
• Healthy volunteers: Accepted

Summary

PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers

Detailed description

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	DWJ1511	Test drug: DWJ1511
DRUG	DWC202501	Comparator: DWC202501

Timeline

• Start date: 2025-09-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2025-08-27
• Last updated: 2025-08-28

Locations

1 site across 1 country: South Korea