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NCT Number: NCT07046715

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

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

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Key information

Conditions

Healthy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bumin Hospital

Seoul, Gangseo-gu, 07590, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-5222

Drug

single dose administration (DA-5222 one tablet once a day)

DA-5222-R1

Drug

single dose administration (DA-5222-R1 one tablet once a day)

DA-5222-R2

Drug

single dose administration (DA-5222-R2 one tablet once a day)

DA-5222-R3

Drug

single dose administration (DA-5222-R3 one tablet once a day)

Primary outcomes

  1. AUCt

    Time frame: pre-dose~48 hours post-dose

    Area Under the Curve

  2. Cmax

    Time frame: pre-dose~48 hours post-dose

    Maximum Plasma Concentration

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Randomized, Fed, 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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