Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 in Healthy Adult Volunteers

Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 in Healthy Adult Volunteers Under Fasting Conditions

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05954247

Enrollment

Registered

2023-07-20

Start date

2023-08-01

Completion date

2023-12-01

Last updated

2023-07-24

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 evaluate the safety and pharmacokinetic characteristics after administration of DWJ1543 in healty adult volunteers.

Detailed description

The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWJ1543.

Interventions

DRUGDWJ1543

DWJ1543

DRUGDWC202216

DWC202216

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* Over 19 year old * Healthy adult volunteers

Exclusion criteria

* Eye disorders including cataracts * Respiratory disorders including interstitial lung disease and pneumonitis and venous thromboembolic disorders

Design outcomes

Primary

Measure	Time frame
Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1543	At pre-dose (0 hour), and post-dose 1 to 120 hour.
Area under the curve from the time of dosing to the last measurable concentration(AUClast) of DWJ1543	At pre-dose (0 hour), and post-dose 1 to 120 hour.

Outcome results

None listed

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