A Study to Evaluate Drug-drug Interactions Between BR9006-1 and BR9006-2 in Healthy Male Volunteers.
NCT04485585 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2020-10-28
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.
Conditions
- Benign Prostatic Hyperplasia (BPH)
- Overactive Bladder
Interventions
- 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
Sponsors & Collaborators
-
Boryung Pharmaceutical Co., Ltd
lead INDUSTRY
Principal Investigators
-
An-Hye Kim · CHA University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-07-20
- Primary Completion
- 2020-08-16
- Completion
- 2020-08-26
Countries
- South Korea
Study Locations
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