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

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.

Official Title
-----------------
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

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: BR9001
* Drug: BR900A


Participation Criteria
=================
Eligibility 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).

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>BR900A - Wash out - BR9001 | Drug: BR9001<br>* BR9001 is a test drug as generic<br>Drug: BR900A<br>* BR900A is a reference drug<br>|
| Experimental: Sequence 2<br>BR9001 - Wash out - BR900A | Drug: BR9001<br>* BR9001 is a test drug as generic<br>Drug: BR900A<br>* BR900A is a reference drug<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Generic