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

NCT04889651 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-07-22

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

BR9004

BR9004: Abiraterone acetate 200mg, Boryung Pharmaceutical Co., Ltd.

DRUG

BR9004-1

BR9004-1: Zytiga Tab. 500mg (Abiraterone acetate 500mg), Janssen Korea

Sponsors & Collaborators

  • Boryung Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • An-Hye Kim · CHA University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2021-06-08
Completion
2021-06-22

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04889651 on ClinicalTrials.gov