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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

BR9001

BR900A

About this trial

This is an interventional other trial for Rheumatoid Arthritis focused on measuring Generic

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Kyungpook National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Sequence 1

Sequence 2

Arm Description

BR900A - Wash out - BR9001

BR9001 - Wash out - BR900A

Outcomes

Primary Outcome Measures

Cmax

Maximum concentration of drug in plasma of BR9001 and BR900A

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03718611

First Posted

October 23, 2018

Last Updated

July 5, 2019

Sponsor

Boryung Pharmaceutical Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03718611

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

October 22, 2018 (Actual)

Primary Completion Date

March 18, 2019 (Actual)

Study Completion Date

May 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boryung Pharmaceutical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Generic

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequence 1

Arm Type

Experimental

Arm Description

BR900A - Wash out - BR9001

Arm Title

Sequence 2

Arm Type

Experimental

Arm Description

BR9001 - Wash out - BR900A

Intervention Type

Drug

Intervention Name(s)

BR9001

Intervention Description

BR9001 is a test drug as generic

Intervention Type

Drug

Intervention Name(s)

BR900A

Intervention Description

BR900A is a reference drug

Primary Outcome Measure Information:

Title

Cmax

Description

Maximum concentration of drug in plasma of BR9001 and BR900A

Time Frame

0-24 hours after administration

Title

AUClast

Description

Area under the plasma drug concentration-time curve over the time interval from 0 to the last observed plasma concentration of BR9001 and BR900A

Time Frame

0-24 hours after administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Young-Ran Yoon, M.D. PhD

Organizational Affiliation

Kyungpook National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kyungpook National University Hospital

City

Daegu

ZIP/Postal Code

700-721

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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