Study to Evaluate the Effect of Food on the Pharmacokinetics and Pharmacodynamics Characteristics in Healthy Adult Volunteers

A Randomized, Open-label, Oral in healthy volunteers

Completed

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Key information

Conditions

GERD (Gastroesophageal Reflux Disease) Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

19 year–50 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 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

DW4421

Drug

DW4421 on fasted or fed condition

Primary outcomes

Peak Plasma Concentration (Cmax)

Time frame: up to 48 hours

Cmax of DW4421
Area under the plasma concentration versus time curve (AUC)

Time frame: up to 48 hours

AUC of DW4421

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase 1 Clinical Trial to Evaluate the Effect of Food on the Safety, Pharmacokinetics and Pharmacodynamics Characteristics of DW4421 in Healthy Adult Volunteers

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jan 23, 2026
Registry last updated: Jan 23, 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.

Published trials that share one or more normalized conditions with this study.

Completed