RecruitingPhase 1NCT07633691

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

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

Sponsor

Dong-A ST Co., Ltd.

Enrollment

12 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Adult

Summary

This study will exploratively evaluate the safety, tolerability and pharmacokinetics of DA-5223 compared with DA-5223-R 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 1 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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