NCT04889651

A Study to Compare the Pharmacokinetics and Safety Between BR9004 and BR9004-1 in Healthy Male Volunteers

A Randomized, Open Label, Single Dose, Full Replicated Crossover Study to Compare the Pharmacokinetics and Safety Between BR9004 and BR9004-1 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To compare the pharmacokinetics and safety between BR9004 and BR9004-1 in healthy male subjects after a single-dose administration while fasting.

Detailed description

This is a randomized, open label, single dose, full replicated crossover study to compare the pharmacokinetics and safety between BR9004 and BR9004-1 in healthy male subjects under fasting conditions. To this end, subjects were divided into two sequence groups \[Sequence A (TRTR) \& Sequence B (RTRT), T: BR9004, single oral administration, R: BR9004-1, single oral administration\].

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	BR9004	BR9004: Abiraterone acetate 200mg, Boryung Pharmaceutical Co., Ltd.
DRUG	BR9004-1	BR9004-1: Zytiga Tab. 500mg (Abiraterone acetate 500mg), Janssen Korea

Timeline

• Start date: 2021-04-15
• Primary completion: 2021-06-08
• Completion: 2021-06-22
• First posted: 2021-05-17
• Last updated: 2021-07-22

Locations

1 site across 1 country: South Korea