Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 With DWC202307 in Healthy Adult Volunteers

Daewoong Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: DWJ1543; Drug: DWC202216; Drug: DWC202307

Study type: Interventional

Funder types: Industry

Identifiers

NCT05954338

DW_DWJ1543102

Details and patient eligibility

About

This study aims to evaluate the safety and the pharmacokinetics of DWJ1543 with concomitant multiple oral doses of DWC202307 in healthy 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: 52 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 19 year old
• Healthy adult volunteer

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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52 participants in 2 patient groups

Intervention: DWC202307 + DWJ1543

Experimental group

Treatment:

Drug: DWJ1543

Drug: DWC202307

Intervention: DWC202307 + DWC202216

Experimental group

Treatment:

Drug: DWC202216

Drug: DWC202307