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

Phase 1

Not yet recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: DWC202216; Drug: DWJ1543

• Registration Number: NCT05954247
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-20
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24
• Study Start: 2023-08-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention: DWC202216	DWC202216	-
Intervention: DWJ1543	DWJ1543	-

Primary Outcome Measures

Name	Time	Method
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.
Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1543	At pre-dose (0 hour), and post-dose 1 to 120 hour.