To Evaluate Effect of Food of DA-5222 in Healthy Adult Subjects
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of DA-5222 in Healthy Adult Subjects
1 other identifier
interventional
32
1 country
1
Brief Summary
This study is to evaluate the effect of food on pharmacokinetics of DA-5222 in healthy adult subjects
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 May 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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2025
CompletedStudy Start
First participant enrolled
May 21, 2025
CompletedFirst Posted
Study publicly available on registry
May 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedMay 28, 2025
May 1, 2025
1 month
May 19, 2025
May 19, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
AUCt
area under the curve
pre-dose~72 hours post-dose
Cmax
maximum plasma concentration
pre-dose~72 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, South Korea, South Korea
Central Study Contacts
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
May 19, 2025
First Posted
May 28, 2025
Study Start
May 21, 2025
Primary Completion
July 1, 2025
Study Completion
July 1, 2025
Last Updated
May 28, 2025
Record last verified: 2025-05