NCT07382661

Brief Summary

Drug-Drug Interaction between DW4421 and Amoxicillin/Clarithromycin

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
5mo left

Started Feb 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Feb 2026Oct 2026

First Submitted

Initial submission to the registry

January 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

January 27, 2026

Last Update Submit

February 2, 2026

Conditions

Healthy Adult Volunteers

Outcome Measures

Primary Outcomes (2)

  • Cmax,ss: Maximum concentration of DW4421, DW4421-1 and DW4421-2 at steady state

    Up to day 6 or day 7

  • AUCτ,ss: Area under the drug concentration-time curve of DW4421, DW4421-1, DW4421-2 within a dosing interval at steady state

    Up to day 6 or day 7

Study Arms (6)

Sequence 1

EXPERIMENTAL

A-B-C (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid)

Drug: DW4421Drug: DW4421-1Drug: DW4421-2

Sequence 2

EXPERIMENTAL

A-C-B (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid)

Drug: DW4421Drug: DW4421-1Drug: DW4421-2

Sequence 3

EXPERIMENTAL

B-A-B (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid)

Drug: DW4421Drug: DW4421-1Drug: DW4421-2

Sequence 4

EXPERIMENTAL

B-C-A (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid)

Drug: DW4421Drug: DW4421-1Drug: DW4421-2

Sequence 5

EXPERIMENTAL

C-A-B (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid)

Drug: DW4421Drug: DW4421-1Drug: DW4421-2

Sequence 6

EXPERIMENTAL

C-B-A (A: DW4421 1T bid; B: DW4421-1 2C bid + DW4421-2 1T bid; C: DW4421 1T bid + DW4421-1 2C bid + DW4421-2 1T bid)

Drug: DW4421Drug: DW4421-1Drug: DW4421-2

Interventions

DW4421DRUG

1 tablet will be orally administered

Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
DW4421-1DRUG

2 capsules will be orally administered

Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
DW4421-2DRUG

1 tablet will be orally administered

Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult aged 19 to 50 (inclusive) years, at the time of screening.
  • Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.

You may not qualify if:

  • Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 3, 2026

Study Start

February 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations

KR(1)