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

NCT07319559 — Phase 1, Completed, 55 participants, Daewon Pharmaceutical Co., Ltd.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07319559
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	55 (Actual)
Sponsor	Daewon Pharmaceutical Co., Ltd. (Industry)
Conditions	Mixed Dyslipidemia
Interventions	DW5124, DW5124-R (Drug)
Dates	start 2025-05-08, primary completion 2025-05-11, completion 2025-06-05, first posted 2026-01-06, last updated 2026-01-06
Locations	1 site in South Korea

-Summary

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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Sequence A	Experimental	Drug: DW5124; Drug: DW5124-R	cross-over
Sequence B	Experimental	Drug: DW5124; Drug: DW5124-R	cross-over
Sequence C	Experimental	Drug: DW5124; Drug: DW5124-R	cross-over
Sequence D	Experimental	Drug: DW5124; Drug: DW5124-R	cross-over
Sequence E	Experimental	Drug: DW5124; Drug: DW5124-R	cross-over
Sequence F	Experimental	Drug: DW5124; Drug: DW5124-R	cross-over

DW5124 (Drug): DW5124 on fasted or fed condition
DW5124-R (Drug): DW5124-R on fasted or fed condition

+Outcome measures

Primary outcomes

Peak Plasma Concentration (Cmax) [up to 72 hour]: Pharmacokinetics of DW5124-fed and DW5124-fasting, Pharmacokinetics of DW5124-fed and DW5124-R-fed
Area under the plasma concentration versus time curve (AUC) [up to 72 hour]: Pharmacokinetics of DW5124-fed and DW5124-fasting, Pharmacokinetics of DW5124-fed and DW5124-R-fed

Secondary outcomes

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

+Eligibility

Sex: All, ages: 19 Years to 65 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Chungbuk National University Hospital	Cheongju-si	South Korea