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
1 other identifier
interventional
70
1 country
1
Brief Summary
A bioequivalence study comparing DWJ1445 and DWC202506 in healthy adults
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2025
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 14, 2025
CompletedFirst Submitted
Initial submission to the registry
November 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2025
CompletedFirst Posted
Study publicly available on registry
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2025
CompletedDecember 3, 2025
November 1, 2025
9 days
November 20, 2025
December 2, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Area under the plasma drug concentration-time curve from time 0 to infinity
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]
0-24 hours
Time of peak concentration [Tmax]
0-24 hours
Terminal phase of half-life [t1/2]
0-24 hours
Study Arms (2)
A(RT)
EXPERIMENTAL35 subjects, Cross-over, Single dose DWC202506 on period 1, Single dose of DWJ1445 on period 2
B(TR)
EXPERIMENTAL35 subjects, Cross-over, Single dose DWJ1445 on period 1, Single dose of DWC202506 on period 2
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
H Plus Yangji Hospital
Seoul, South Korea
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2025
First Posted
December 1, 2025
Study Start
November 14, 2025
Primary Completion
November 23, 2025
Study Completion
December 2, 2025
Last Updated
December 3, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share