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
An Open-label, Randomized, Fed, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety After Single-administration of DA-5222 and Co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in Healthy Adult Subjects
1 other identifier
interventional
40
1 country
1
Brief Summary
This study is to compare pharmacokinetics and safety profiles of 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Jul 2025
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2025
CompletedFirst Posted
Study publicly available on registry
July 1, 2025
CompletedStudy Start
First participant enrolled
July 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2025
CompletedNovember 17, 2025
November 1, 2025
1 month
June 23, 2025
November 13, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
AUCt
Area Under the Curve
pre-dose~48 hours post-dose
Cmax
Maximum Plasma Concentration
pre-dose~48 hours post-dose
Study Arms (2)
Sequence A
EXPERIMENTALSequence B
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers
- BMI between 18 and 30 kg/m2
- Body weight: Male≥50kg, Female≥45kg
- Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study
You may not qualify if:
- Subjects with clinically significant medical history
- Subjects with history of drug abuse or addicted
- Subjects with allergy or drug hypersensitivity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bumin Hospital
Seoul, Gangseo-gu, 07590, South Korea
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2025
First Posted
July 1, 2025
Study Start
July 7, 2025
Primary Completion
August 19, 2025
Study Completion
August 19, 2025
Last Updated
November 17, 2025
Record last verified: 2025-11