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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03718611

Enrollment

Registered

2018-10-24

Start date

2018-10-22

Completion date

2019-05-17

Last updated

2019-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Generic

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.

Interventions

DRUGBR9001

BR9001 is a test drug as generic

DRUGBR900A

BR900A is a reference drug

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
Cmax	0-24 hours after administration	Maximum concentration of drug in plasma of BR9001 and BR900A
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026