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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03718611
• Other study ID #: BR-TFD-CT-101
• Status: Completed
• Phase: Phase 1
• Start date: October 22, 2018
• Est. completion date: May 17, 2019

Study information

• Verified date: March 2019
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 17, 2019
• Est. primary completion date: March 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• BR9001
BR9001 is a test drug as generic
• BR900A
BR900A is a reference drug

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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