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Not yet recruiting NCT06993181

Clinical Trial of Comparing DA-5222 Single-administration and Co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in Healthy Adult Subjects

Phase I Interventional Healthy

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: DA-5222, DA-5222-R1, DA-5222-R2, DA-5222-R3.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: from 19 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

An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety After Single-administration of DA-5222 and Co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in Healthy Adult Subjects

Overview

This study is to compare pharmacokinetics and safety profiles of DA-5222 single-administration and co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in healthy adult subjects

Interventions

  • Drug DA-5222
    single dose administration (DA-5222 one tablet once a day)
  • Drug DA-5222-R1
    single dose administration (DA-5222-R1 one tablet once a day)
  • Drug DA-5222-R2
    single dose administration (DA-5222-R2 one tablet once a day)
  • Drug DA-5222-R3
    single dose administration (DA-5222-R3 one tablet once a day)

Primary outcome measures

  • AUCt [Time frame: pre-dose~72 hours post-dose]
  • Cmax [Time frame: pre-dose~72 hours post-dose]

Eligibility criteria

Inclusion criteria

  • Healthy volunteers
  • BMI between 18 and 30 kg/m2
  • Body weight: Male≥50kg, Female≥45kg
  • Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study

Exclusion criteria

  • Subjects with clinically significant medical history
  • Subjects with history of drug abuse or addicted
  • Subjects with allergy or drug hypersensitivity

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
Treatment

Study locations

South Korea · 1 center
  • Bumin Hospital — Seoul

Identifiers

NCT: NCT06993181 · DA5222_BE_I

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗