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

Boryung

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: BR900A; Drug: BR9001

Study type: Interventional

Funder types: Industry

Identifiers

NCT03718611

BR-TFD-CT-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Sequence 1

Experimental group

Description:

BR900A - Wash out - BR9001

Treatment:

Drug: BR900A

Drug: BR9001

Sequence 2

Experimental group

Description:

BR9001 - Wash out - BR900A

Treatment:

Drug: BR900A

Drug: BR9001