NCT07256600

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 64 Years
• Healthy volunteers: Accepted

Summary

A bioequivalence study comparing DWJ1445 and DWC202506 in healthy adults

Detailed description

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	DWJ1445	1 tablet, Orally
DRUG	DWC202506	1 tablet, Orally

Timeline

• Start date: 2025-11-14
• Primary completion: 2025-11-23
• Completion: 2025-12-02
• First posted: 2025-12-01
• Last updated: 2025-12-03

Locations

1 site across 1 country: South Korea