RecruitingPhase 1NCT07007520

A Study to Evaluate the Food Effect on the Pharmacokinetics of DA-5223 in Healthy Adult Subjects

An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Food Effect on the Pharmacokinetics of DA-5223 in Healthy Adult Subjects


Sponsor

Dong-A ST Co., Ltd.

Enrollment

38 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate the food effect on the pharmacokinetics of DA-5223 in healthy adult subjects


Eligibility

Min Age: 19 YearsMax Age: 55 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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 6 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization
  • The subjects who are pregnant or lactating

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDA-5223(Fasting)

once a day

DRUGDA-5223(Fed)

once a day


Locations(1)

CHA Global Clinical Trials Center

Seongnam-si, Gyeonggi-do, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07007520


Related Trials