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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: DWJ1445; Drug: DWC202506

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • H Plus Yangji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A(RT); 35 subjects, Cross-over, Single dose DWC202506 on period 1, Single dose of DWJ1445 on period 2	Drug: DWJ1445; 1 tablet, Orally; Drug: DWC202506; 1 tablet, Orally
Experimental: B(TR); 35 subjects, Cross-over, Single dose DWJ1445 on period 1, Single dose of DWC202506 on period 2	Drug: DWJ1445; 1 tablet, Orally; Drug: DWC202506; 1 tablet, Orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma drug concentration-time curve [AUCt]	Area under the plasma drug concentration-time curve [AUCt] of DWJ1445 and DWC202506	0-24 hours
Maximum plasma concentration [Cmax]	Maximum plasma concentration [Cmax] of DWJ1445 and DWC202506	0-24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma drug concentration-time curve from time 0 to infinity	Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of DWJ1445 and DWC202506	0-24 hours
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]	Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] of DWJ1445 and DWC202506	0-24 hours
Time of peak concentration [Tmax]	Time of peak concentration [Tmax] of Amoxicillin & Clavulanic acid of DWJ1445 and DWC202506	0-24 hours
Terminal phase of half-life [t1/2]	Terminal phase of half-life of DWJ1445 and DWC202506	0-24 hours

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2025
• Primary Completion (Actual): November 23, 2025
• Study Completion (Actual): December 2, 2025

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Estimated): December 1, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWJ1445102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No