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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: BR9001; Drug: BR900A

• Registration Number: NCT03718611
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

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 Timeline

• Study Start: 2018-10-22
• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-24
• Status Verified: 2019-03
• Primary Completion: 2019-03-18
• Study Completion: 2019-05-17
• Last Update Submitted: 2019-07-05
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	BR9001	BR900A - Wash out - BR9001
Sequence 1	BR900A	BR900A - Wash out - BR9001
Sequence 2	BR900A	BR9001 - Wash out - BR900A
Sequence 2	BR9001	BR9001 - Wash out - BR900A

Primary Outcome Measures

Name	Time	Method
AUClast	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	0-24 hours after administration	Maximum concentration of drug in plasma of BR9001 and BR900A

Trial Locations

Locations (1)

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of