Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1567 in Healthy Adult Volunteers

An Open-label, Randomized, 2x4 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1567 and DWC202312 in Healthy Volunteers

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06109259

Enrollment

Registered

2023-10-31

Start date

2023-11-06

Completion date

2023-12-31

Last updated

2023-10-31

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

Conditions

Healthy Volunteers

Brief summary

This study aims to compare the pharmacokinetics and safety following administration of DWJ1567 and DWC202312 in healthy volunteers

Detailed description

The study design is a Randomized, Open-label, Oral, Single-dose, Four-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUCt of DWJ1567 and DWC202312. Secondary endpoints were AUCinf, Tmax, t1/2 of DWJ1567 and DWC202312.

Interventions

DRUGDWJ1567

One tablet of DWJ1567

DRUGDWC202312

One tablet of DWC202312

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Over 19 year old

Exclusion criteria

* Galactose intolerance * Lapp lactase deficiency

Design outcomes

Primary

Measure	Time frame
Cmax,ss of DWJ1567 and DWC202312	At pre-dose (0 hour), and post-dose 0 to 72 hour.
AUCt of DWJ1567 and DWC202312	At pre-dose (0 hour), and post-dose 0 to 72 hour.

Secondary

Measure	Time frame
AUCinf of DWJ1567 and DWC202312	At pre-dose (0 hour), and post-dose 0 to 72 hour
Tmax of DWJ1567 and DWC202312	At pre-dose (0 hour), and post-dose 0 to 72 hour
AUCt/AUCinf of DWJ1567 and DWC202312	At pre-dose (0 hour), and post-dose 0 to 72 hour
t1/2 of DWJ1567 and DWC202312	At pre-dose (0 hour), and post-dose 0 to 72 hour

Countries

South Korea

Contacts

Primary ContactSeung-Hyun Kang, MD, Ph D

juspa@newyjh.com070-4665-9490

Outcome results

None listed

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