Clinical Trial to Evaluate the Safety, Pharmacokinetic Characteristics of DW5124 and DW5124-R, and the Effect of Food on DW5124 in Healthy Adult Volunteers

This study aimed to evaluate the safety and pharmacokinetic characteristics of DW5124 and DW5124-R, and the effect of food on DW5124, in healthy adult volunteers.

Study Overview

• Status: Completed
• Conditions: Mixed Dyslipidemia
• Intervention / Treatment: Drug: DW5124; Drug: DW5124-R

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Cheongju-si, South Korea
    • Chungbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy Volunteers who are ≥19 years and >65 years old
• Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2

Exclusion Criteria:

• Clinically significant Medical History
• In the case of women, pregnant(Urine-HCG positive) or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A; cross-over	Drug: DW5124; DW5124 on fasted or fed condition; Drug: DW5124-R; DW5124-R on fasted or fed condition
Experimental: Sequence B; cross-over	Drug: DW5124; DW5124 on fasted or fed condition; Drug: DW5124-R; DW5124-R on fasted or fed condition
Experimental: Sequence C; cross-over	Drug: DW5124; DW5124 on fasted or fed condition; Drug: DW5124-R; DW5124-R on fasted or fed condition
Experimental: Sequence D; cross-over	Drug: DW5124; DW5124 on fasted or fed condition; Drug: DW5124-R; DW5124-R on fasted or fed condition
Experimental: Sequence E; cross-over	Drug: DW5124; DW5124 on fasted or fed condition; Drug: DW5124-R; DW5124-R on fasted or fed condition
Experimental: Sequence F; cross-over	Drug: DW5124; DW5124 on fasted or fed condition; Drug: DW5124-R; DW5124-R on fasted or fed condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax)	Pharmacokinetics of DW5124-fed and DW5124-fasting, Pharmacokinetics of DW5124-fed and DW5124-R-fed	up to 72 hour
Area under the plasma concentration versus time curve (AUC)	Pharmacokinetics of DW5124-fed and DW5124-fasting, Pharmacokinetics of DW5124-fed and DW5124-R-fed	up to 72 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to maximum plasma concentration (Tmax)	Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed	up to 72 hour
Terminal half life (t1/2)	Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed	up to 72 hour
Apparent clearance (CL/F)	Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed	up to 72 hour
Apparent volume of distribution (Vd/F)	Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed	up to 72 hour

Collaborators and Investigators

• Sponsor: Daewon Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2025
• Primary Completion (Actual): May 11, 2025
• Study Completion (Actual): June 5, 2025

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: DW5124-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No