Drug-Drug Interaction Between DW4421 and Amoxicillin/Clarithromycin

A Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetics Drug-drug Interaction of DW4421 and Amoxicillin/Clarithromycin in Healthy Adult Volunteers

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07382661

Enrollment

Registered

2026-02-03

Start date

2026-02-01

Completion date

2026-10-01

Last updated

2026-02-04

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

Conditions

Healthy Adult Volunteers

Brief summary

Drug-Drug Interaction between DW4421 and Amoxicillin/Clarithromycin

Interventions

DRUGDW4421

1 tablet will be orally administered

DRUGDW4421-1

2 capsules will be orally administered

DRUGDW4421-2

1 tablet will be orally administered

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Inclusion Criteria: * 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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

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