Pharmacokinetics and Safety Profiles After Administration of DA-5211 and Co-administration of DA-5211-R1 and DA-5211-R2 in Healthy Adult Volunteers
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of DA-5211 and Co-administration of DA-5211-R1 and DA-5211-R2 in Healthy Adult Volunteer
1 other identifier
interventional
42
1 country
1
Brief Summary
Pharmacokinetics and safety Profiles after administration of DA-5211 and co-administration of DA-5211-R1 and DA-5211-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 Dec 2021
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
November 16, 2021
CompletedFirst Posted
Study publicly available on registry
November 23, 2021
CompletedStudy Start
First participant enrolled
December 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2022
CompletedJune 7, 2022
June 1, 2022
2 months
November 16, 2021
June 2, 2022
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
single dose administration (DA-5211-R1 one tablet once a day + DA-5211-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 allergy or drug hypersensitivity
- 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, 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
November 16, 2021
First Posted
November 23, 2021
Study Start
December 18, 2021
Primary Completion
February 22, 2022
Study Completion
February 22, 2022
Last Updated
June 7, 2022
Record last verified: 2022-06