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Enrolling by invitation NCT07364877

A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of DW4421 and DW4421S in Healthy Adult Volunteers

Phase I Interventional Healthy Adult Volunteer

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, DW4421S.
Who it may be relevant to
Registry conditions: Healthy Adult Volunteer. 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 Randomized, Open-label, Single-dose, 2-sequence, Two-period, Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of DW4421 and DW4421S in Healthy Adult Volunteers

Overview

Safety and pharmacokinetic characteristics evaluation of DW4421 and DW4421S

Interventions

  • Drug DW4421
    DW4421 or DW4421S
  • Drug DW4421S
    DW4421 or DW4421S

Primary outcome measures

  • Cmax [Time frame: up to 48 hour]
  • AUC0-t [Time frame: up to 48 hour]

Eligibility criteria

Inclusion criteria

  • Healthy adult aged 19 to 50 (inclusive) years
  • Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive)

Exclusion criteria

  • 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: NCT07364877 · DW4421-104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗