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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-22

Study Completion Date

2019-05-17

Brief Summary

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

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Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sequence 1

BR900A - Wash out - BR9001

Group Type EXPERIMENTAL

BR9001

Intervention Type DRUG

BR9001 is a test drug as generic

BR900A

Intervention Type DRUG

BR900A is a reference drug

Sequence 2

BR9001 - Wash out - BR900A

Group Type EXPERIMENTAL

BR9001

Intervention Type DRUG

BR9001 is a test drug as generic

BR900A

Intervention Type DRUG

BR900A is a reference drug

Interventions

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BR9001

BR9001 is a test drug as generic

Intervention Type DRUG

BR900A

BR900A is a reference drug

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes