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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07364838

Enrollment

Registered

2026-01-23

Start date

2024-11-21

Completion date

2025-04-08

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD (Gastroesophageal Reflux Disease)

Brief summary

A Randomized, Open-label, Oral in healthy volunteers

Interventions

DRUGDW4421

DW4421 on fasted or fed condition

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Peak Plasma Concentration (Cmax)	up to 48 hours	Cmax of DW4421
Area under the plasma concentration versus time curve (AUC)	up to 48 hours	AUC of DW4421

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026