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

NCT ID: NCT07319559

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-08

Study Completion Date

2025-06-05

Brief Summary

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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.

Detailed Description

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Conditions

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Mixed Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence A

cross-over

Group Type EXPERIMENTAL

DW5124

Intervention Type DRUG

DW5124 on fasted or fed condition

DW5124-R

Intervention Type DRUG

DW5124-R on fasted or fed condition

Sequence B

cross-over

Group Type EXPERIMENTAL

DW5124

Intervention Type DRUG

DW5124 on fasted or fed condition

DW5124-R

Intervention Type DRUG

DW5124-R on fasted or fed condition

Sequence C

cross-over

Group Type EXPERIMENTAL

DW5124

Intervention Type DRUG

DW5124 on fasted or fed condition

DW5124-R

Intervention Type DRUG

DW5124-R on fasted or fed condition

Sequence D

cross-over

Group Type EXPERIMENTAL

DW5124

Intervention Type DRUG

DW5124 on fasted or fed condition

DW5124-R

Intervention Type DRUG

DW5124-R on fasted or fed condition

Sequence E

cross-over

Group Type EXPERIMENTAL

DW5124

Intervention Type DRUG

DW5124 on fasted or fed condition

DW5124-R

Intervention Type DRUG

DW5124-R on fasted or fed condition

Sequence F

cross-over

Group Type EXPERIMENTAL

DW5124

Intervention Type DRUG

DW5124 on fasted or fed condition

DW5124-R

Intervention Type DRUG

DW5124-R on fasted or fed condition

Interventions

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DW5124

DW5124 on fasted or fed condition

Intervention Type DRUG

DW5124-R

DW5124-R on fasted or fed condition

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daewon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chungbuk National University Hospital

Cheongju-si, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW5124-101

Identifier Type: -

Identifier Source: org_study_id

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