Actively Recruiting
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
Led by Dong-A ST Co., Ltd. · Updated on 2026-06-08
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and pharmacokinetics of DA-5223 compared with DA-5223-R in healthy adult volunteers. This Phase 1 trial aims to explore these effects in adults aged 19 to 55 years. The study is sponsored by Dong-A ST Co., Ltd. and focuses on healthy individuals without major health issues to understand how these drugs behave in the body. Participants will receive single doses of DA-5223 and DA-5223-R in a randomized, open-label, crossover design. There are two cohorts and two periods where subjects receive these drugs once a day in different sequences. This setup helps researchers compare the two forms of DA-5223 directly within the same individuals. During the study, volunteers will undergo assessments to monitor drug levels in the blood, focusing on measures such as AUClast and Cmax over an 8-hour period. Safety and tolerability will also be closely observed. The study involves healthy adults who agree to participate voluntarily and meet specific weight and health criteria. The total duration and detailed visit schedules are determined by the study protocol.
CONDITIONS
Brief Title
A Study to Exploratively Evaluate the Safety, Tolerability and Pharmacokinetics of DA-5223 Compared With DA-5223-R in Healthy Adult Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Subjects who signed informed consent after understanding the study and voluntarily agreed to participate
You will not qualify if you...
- Subjects with acute illness
- Subjects with history of gastrointestinal disease or surgery affecting drug absorption
- Subjects hypersensitive to any investigational product components or other drug components
- Subjects who have continuously consumed excessive smoking or alcohol within 1 month of screening or who cannot stop smoking, caffeine, or alcohol during hospitalization
- Subjects who are pregnant or lactating
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Two treatment periods with washout in between; each treatment period lasts 1 day
Participants receive single doses of DA-5223 formulations in a randomized crossover design to evaluate safety, tolerability, and pharmacokinetics.
2 dosing visits (in-person) plus washout periods between treatments
Trial Site Locations
Total: 1 location
1
Bumin hospital
Gangseo-gu, Seoul, South Korea, 07590
Actively Recruiting
Research Team
T
Taegon Hong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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