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Not yet recruiting NCT07382661

Drug-Drug Interaction Between DW4421 and Amoxicillin/Clarithromycin

Phase I Interventional Healthy Adult Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DW4421, DW4421-1, DW4421-2.
Who it may be relevant to
Registry conditions: Healthy Adult Volunteers. Basic parameters: 19 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

Drug-Drug Interaction between DW4421 and Amoxicillin/Clarithromycin

Interventions

  • Drug DW4421
    1 tablet will be orally administered
  • Drug DW4421-1
    2 capsules will be orally administered
  • Drug DW4421-2
    1 tablet will be orally administered

Primary outcome measures

  • Cmax,ss: Maximum concentration of DW4421, DW4421-1 and DW4421-2 at steady state [Time frame: 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 [Time frame: Up to day 6 or day 7]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

South Korea · 1 center
  • Chungbuk National University Hospital — Cheongju-si

Identifiers

NCT: NCT07382661 · DW4421-103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗