Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Study to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Single Administration of DA-5221_01 and Concomitant Administration of DA-5221_01-R1 and DA-5221_01-R2 Under Fasting Conditions in Healthy Adult Volunteers
1 other identifier
interventional
44
1 country
1
Brief Summary
Pharmacokinetics and Safety Profiles After Administration of DA-5221\_01 and Co-administration of 5221\_01-R1 and DA-5221\_01-R2 in Healthy Adult Volunteers
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 Sep 2024
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
September 25, 2024
CompletedFirst Posted
Study publicly available on registry
September 27, 2024
CompletedStudy Start
First participant enrolled
September 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 18, 2024
CompletedSeptember 27, 2024
September 1, 2024
2 months
September 25, 2024
September 25, 2024
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-do
Study Arms (2)
Experimental: Sequence A
EXPERIMENTALExperimental: Sequence B
EXPERIMENTALInterventions
single dose administration (DA-5221\_01 one tablet once a day)
single dose administration (DA-5221\_01-R1 one tablet once a day + DA-5221\_01-R2 one tablet once a day)
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bumin Hospital
Seoul, South Korea, 07590, 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
September 25, 2024
First Posted
September 27, 2024
Study Start
September 30, 2024
Primary Completion
November 14, 2024
Study Completion
November 18, 2024
Last Updated
September 27, 2024
Record last verified: 2024-09