NCT03718611

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	BR9001	BR9001 is a test drug as generic
DRUG	BR900A	BR900A is a reference drug

Timeline

• Start date: 2018-10-22
• Primary completion: 2019-03-18
• Completion: 2019-05-17
• First posted: 2018-10-24
• Last updated: 2019-07-08

Locations

1 site across 1 country: South Korea