Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects (DA-2811)
An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA 2811 in Healthy Subjects
1 other identifier
interventional
30
1 country
1
Brief Summary
This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and DA-2811-R after a single oral dose in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Jul 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
June 16, 2021
CompletedFirst Posted
Study publicly available on registry
June 24, 2021
CompletedStudy Start
First participant enrolled
July 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2021
CompletedJune 6, 2022
June 1, 2022
1 month
June 16, 2021
June 2, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
AUClast
Area under the plasma concentration-time curve from time zero to time the last quantifiable time
pre-dose~48 hours post-dose
Cmax
Maximum plasma concentration
pre-dose~48 hours post-dose
Study Arms (2)
Sequence I
EXPERIMENTALSequence II
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy male and/or female subjects
- BMI between 18.5 and 29.9 kg/m2 and weigh at least 50 kg
- Volunteer who totally understands the progress of this clinical trial, make decision by his or her free will, and signed a consent form to follow the progress
You may not qualify if:
- Volunteer who has present or past history of clinically significant cardiovascular, respiratory, urinary, gastrointestinal, hepatic, renal, skin, immunological, musculoskeletal, endocrinal, neurological, psychiatric and/or hematological disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Gyeonggi-do, Seongnam-si, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Chung JaeYong
Seoul National University Bundang Hospital
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 16, 2021
First Posted
June 24, 2021
Study Start
July 8, 2021
Primary Completion
August 20, 2021
Study Completion
August 20, 2021
Last Updated
June 6, 2022
Record last verified: 2022-06