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Completed

NCT Number: NCT03718611

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

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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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kyungpook National University Hospital

Daegu, 700-721, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

BR9001

Drug

BR9001 is a test drug as generic

BR900A

Drug

BR900A is a reference drug

Primary outcomes

  1. Cmax

    Time frame: 0-24 hours after administration

    Maximum concentration of drug in plasma of BR9001 and BR900A

  2. AUClast

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 24, 2018
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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