A Study to Evaluate the Pharmacokinetics and Safety Between Single Oral Administration of BR3006 and Co-administration of BR3006A, BR3006B and BR3006C in Healthy Adult Volunteers Under Fed Conditions
- Sponsor
- Boryung Pharmaceutical Co., Ltd
- Study ID
- NCT06890299
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- BR3006 — DRUGOne tablet administered alone
- BR3006A — DRUGOne tablet administered alone
- BR3006B — DRUGOne tablet administered alone
- BR3006C — DRUGOne tablet administered alone
Study Details
The purpose of this clinical study is to evaluate the pharmacokinetics and safety between single oral administration of BR3006 and co-administration of BR3006A, BR3006B and BR3006C in healthy adult volunteers under fed conditions
Key Dates
- First listed
- Mar 24, 2025
- Start date
- Dec 5, 2024
- Status verified
- Mar 2025
- Primary completion
- Jan 12, 2025
- Completion
- Jan 12, 2025
Study Design
- Enrollment
- 40 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: BR3006
- Active Comparator: BR3006A+BR3006B+BR3006C
Primary Outcome Measure
AUCt [ Time Frame: 0-48 hours after administration ]
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