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

July 5, 2019 updated by: Boryung Pharmaceutical Co., Ltd

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-721
        • Kyungpook National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sequence 1
BR900A - Wash out - BR9001
Drug: BR9001
BR9001 is a test drug as generic
Drug: BR900A
BR900A is a reference drug
EXPERIMENTAL: Sequence 2
BR9001 - Wash out - BR900A
Drug: BR9001
BR9001 is a test drug as generic
Drug: BR900A
BR900A is a reference drug

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boryung Pharmaceutical Co., Ltd

Investigators

  • Principal Investigator: Young-Ran Yoon, M.D. PhD, Kyungpook National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 22, 2018

Primary Completion (ACTUAL)

March 18, 2019

Study Completion (ACTUAL)

May 17, 2019

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

October 23, 2018

First Posted (ACTUAL)

October 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-TFD-CT-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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