Overview
To Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy Subjects
Status:
Completed
Completed
Trial end date:
2019-05-17
2019-05-17
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate the pharmacokinetics and safety of oral administration of BR9001 compared with BR900A in healthy subjectsPhase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Criteria
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).