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Completed

NCT Number: NCT07633691

A Study to Exploratively Evaluate the Safety, Tolerability and Pharmacokinetics of DA-5223 Compared With DA-5223-R in Healthy Adult Subjects

This study will exploratively evaluate the safety, tolerability and pharmacokinetics of DA-5223 compared with DA-5223-R in healthy adult subjects

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Key information

Conditions

Healthy Adult

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bumin hospital

Gangseo-gu, Seoul, 07590, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult male or female, 19 years to 55 years
  • Male weighing 50 kg or more, female weighing 45 kg or more with a body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2
  • The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate

Exclusion criteria

  • The subjects with acute illness
  • The subjects with a history of gastrointestinal disease or surgery that may affect the absorption of Investigational Product
  • The subjects hypersensitive to any of the Investigational Product components or other drug components
  • The subjects who have continuously consumed excessive smoking or alcohol within 1 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization
  • The subjects who are pregnant or lactating

Treatment and study plan

DA-5223-R

Drug

once a day

DA-5223-F

Drug

once a day

DA-5223-M

Drug

once a day

Primary outcomes

  1. AUClast

    Time frame: 0~8 hours

    Area under the plasma concentration-time curve from time zero to time the last quantifiable time

  2. Cmax

    Time frame: 0~8 hours

    Peak Plasma Concentration

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Randomized, Single-dose, Two-Cohort, Two-Period, Crossover Study to Exploratively Evaluate the Safety, Tolerability and Pharmacokinetics of DA-5223 Compared With DA-5223-R in Healthy Adult Subjects

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2026
Registry last updated
Jul 15, 2026

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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