To Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy Subjects

• Status: Completed
• Trial end date: 2019-05-17
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the pharmacokinetics and safety of oral administration of BR9001 compared with BR900A in healthy subjects

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• 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).