NCT04485585

A Study to Evaluate Drug-drug Interactions Between BR9006-1 and BR9006-2 in Healthy Male Volunteers.

An Open Label, One-sequence, 3-period Study to Evaluate Drug-drug Interactions Between BR9006-1 and BR9006-2 in Healthy Male Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate the influence of BR9006-1 and BR9006-2 on pharmacokinetics, safety, and tolerability when administered separately or co-administered to healthy male volunteers.

Detailed description

A total of 36 subjects will be enrolled in one sequence group. The investigational products will be administered according to the treatment groups (T, M, T+M) assigned to one sequence group in Period 1, Period 2, and Period 3.

Conditions

• Benign Prostatic Hyperplasia (BPH)
• Overactive Bladder

Interventions

Type	Name	Description
DRUG	BR9006-1	* Administration to the T/T+M group: 0.2 mg of BR9006-1 will be administered one capsule once a day, five-day repeated-dose
DRUG	BR9006-2	* Administration to the M group: 50 mg of BR9006-2 will be administered one tablet once a day, eleven-day repeated-dose * Administration to the T+M group: 50 mg of BR9006-2 will be administered one tablet once a day, five-day repeated-dose

Timeline

• Start date: 2020-07-20
• Primary completion: 2020-08-16
• Completion: 2020-08-26
• First posted: 2020-07-24
• Last updated: 2020-10-28

Locations

1 site across 1 country: South Korea