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CompletedNCT07364838Updated Jan 23, 2026

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

A Phase 1 interventional study of DW4421 in GERD (Gastroesophageal Reflux Disease), sponsored by Daewon Pharmaceutical Co., Ltd.. Completed at 1 site in South Korea. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by Daewon Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Nov 2024, registered Dec 2025).
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
All
01

Study summary

A Randomized, Open-label, Oral in healthy volunteers

02

Conditions studied

  • GERD (Gastroesophageal Reflux Disease)
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 24 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Daewon Pharmaceutical Co., Ltd. is the lead sponsor of 48 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Clinically significant Medical History
  • In the case of women, pregnant(Urine-HCG positive) or lactating women
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Sequence A

    Cross-over

    Drug: DW4421

  • Experimental
    Sequence B

    Cross-over

    Drug: DW4421

Interventions

  • DrugDW4421

    DW4421 on fasted or fed condition

06

What researchers measure

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Cmax of DW4421

    Time frame: up to 48 hours

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

    AUC of DW4421

    Time frame: up to 48 hours

07

Study locations

1 site
  • Chungbuk National University Hospital
    Cheongju-si, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07364838
Lead sponsor
Daewon Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jan 23, 2026
Start date
Nov 21, 2024
Primary completion
Apr 8, 2025
Completion
Apr 8, 2025
Last update
Jan 23, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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