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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07256600

Enrollment

Registered

2025-12-01

Start date

2025-11-14

Completion date

2025-12-02

Last updated

2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Brief 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.

Interventions

DRUGDWJ1445

1 tablet, Orally

DRUGDWC202506

1 tablet, Orally

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026