A Study to Compare the Pharmacokinetics and Safety Between BR9004 and BR9004-1 in Healthy Male Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Prostate Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 55 years
- Gender
- Only males
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),...
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].
Tracking Information
- NCT #
- NCT04889651
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: An-Hye Kim CHA University
Get Well Soon