To Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy Subjects
A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy Subjects
1 other identifier
interventional
36
1 country
1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics and safety of oral administration of BR9001 compared with BR900A in healthy 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 rheumatoid-arthritis
Started Oct 2018
Shorter than P25 for phase_1 rheumatoid-arthritis
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
Study Start
First participant enrolled
October 22, 2018
CompletedFirst Submitted
Initial submission to the registry
October 23, 2018
CompletedFirst Posted
Study publicly available on registry
October 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2019
CompletedJuly 8, 2019
March 1, 2019
5 months
October 23, 2018
July 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cmax
Maximum concentration of drug in plasma of BR9001 and BR900A
0-24 hours after administration
AUClast
Area under the plasma drug concentration-time curve over the time interval from 0 to the last observed plasma concentration of BR9001 and BR900A
0-24 hours after administration
Study Arms (2)
Sequence 1
EXPERIMENTALBR900A - Wash out - BR9001
Sequence 2
EXPERIMENTALBR9001 - Wash out - BR900A
Interventions
Eligibility Criteria
You may qualify if:
- Adults 19-50 years of age
- Body mass index (BMI) ≥ 18.5 and ≤ 27.0 kg/m\^2 at screening
- Medically healthy with no clinically significant medical history
- No clinically significant result with laboratory test including chemistry, serum, urine test within 3 weeks in prior to administration of investigational product
- Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol
You may not qualify if:
- History or presence of clinically significant medical or psychiatric condition or disease.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Creatinint clearance \< 80 mL/min (using Cockcroft-Gault) at screening.
- Whole blood donation within a 2 months prior to the first dose of study drug.
- Participation in another clinical trial or bioequivalence study within 12 weeks prior to the first dose of study drug(s).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyungpook National University Hospital
Daegu, 700-721, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young-Ran Yoon, M.D. PhD
Kyungpook National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2018
First Posted
October 24, 2018
Study Start
October 22, 2018
Primary Completion
March 18, 2019
Study Completion
May 17, 2019
Last Updated
July 8, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share