A Study to Compare and Evaluate the Safety, Tolerability and Pharmacokinetics Between DA-5223 and DA-5223-R in Healthy Adult Subjects
NCT ID: NCT07007533
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2025-07-04
2025-07-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Trial of Comparing DA-5222 Single-administration and Co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in Healthy Adult Subjects
NCT06993181
Clinical Trial Comparing Single-administration of DA-5222 and Co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in Healthy Adult Subjects in Fed State
NCT07046715
Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects (DA-2811)
NCT04938752
Pharmacokinetics and Safety Profiles of DA-1229_01 in Healthy Subjects at Fed State
NCT07342062
Phamacokinetics and Safety Profiles of DA-1229_01 5/1000mg in Healthy Subjects at Fasting State
NCT05739903
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sequence A
DA-5223-R
once a day
DA-5223
once a day
Sequence B
DA-5223-R
once a day
DA-5223
once a day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DA-5223-R
once a day
DA-5223
once a day
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
19 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHA Global Clinical Trials Center
Seongnam-si, Gyeonggi-do, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DA5223_LSS_I
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.