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
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Interventions
DRUGDA-5223(Fasting)
once a day
DRUGDA-5223(Fed)
once a day
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07007520
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