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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- AUClast
Study Overview
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
Detailed Description
This is an open-label, randomized, crossover study to evaluate the pharmacokinetics and safety. Within each period, randomized subjects will be take 2 dosing regimens that BR9001 or BR900A.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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).
Arms & Interventions
Sequence 1
BR900A - Wash out - BR9001
Intervention: BR9001 (Drug)
Sequence 1
BR900A - Wash out - BR9001
Intervention: BR900A (Drug)
Sequence 2
BR9001 - Wash out - BR900A
Intervention: BR9001 (Drug)
Sequence 2
BR9001 - Wash out - BR900A
Intervention: BR900A (Drug)
Outcomes
Primary Outcomes
AUClast
Time Frame: 0-24 hours after administration
Area under the plasma drug concentration-time curve over the time interval from 0 to the last observed plasma concentration of BR9001 and BR900A
Cmax
Time Frame: 0-24 hours after administration
Maximum concentration of drug in plasma of BR9001 and BR900A
Secondary Outcomes
No secondary outcomes reported