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

Daewoong Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: DWJ1543; Drug: DWC202216

Study type: Interventional

Funder types: Industry

Identifiers

NCT05954247

DW_DWJ1543101

Details and patient eligibility

About

This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1543 in healty adult volunteers.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Intervention: DWJ1543

Experimental group

Treatment:

Drug: DWJ1543

Intervention: DWC202216

Experimental group

Treatment:

Drug: DWC202216