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OpenTrials
Completed

NCT Number: NCT07319559

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.

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Key information

Conditions

Mixed Dyslipidemia

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chungbuk National University Hospital

Cheongju-si, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DW5124

Drug

DW5124 on fasted or fed condition

DW5124-R

Drug

DW5124-R on fasted or fed condition

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: up to 72 hour

    Pharmacokinetics of DW5124-fed and DW5124-fasting, Pharmacokinetics of DW5124-fed and DW5124-R-fed

  2. Area under the plasma concentration versus time curve (AUC)

    Time frame: up to 72 hour

    Pharmacokinetics of DW5124-fed and DW5124-fasting, Pharmacokinetics of DW5124-fed and DW5124-R-fed

Secondary outcomes

  1. Time to maximum plasma concentration (Tmax)

    Time frame: up to 72 hour

    Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed

  2. Terminal half life (t1/2)

    Time frame: up to 72 hour

    Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed

  3. Apparent clearance (CL/F)

    Time frame: up to 72 hour

    Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed

  4. Apparent volume of distribution (Vd/F)

    Time frame: up to 72 hour

    Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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