A Clinical Trial to Compare the Pharmacokinetics and Safety of "BR1016C" With "BR1016D" in Healthy Volunteers
NCT05102266 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2023-05-24
Summary
To evaluate the pharmacokinetic properties and safety of "BR1016C" and "BR1016D" in healthy adults.
Conditions
Interventions
- DRUG
-
BR1016C
All subjects who have been fasting for at least 10 hours prior to administration will take 1 tablet of study drug or comparator orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
- DRUG
-
BR1016D
All subjects who have been fasting for at least 10 hours prior to administration will take 1 tablet of study drug or comparator orally with 150 mL of water at room temperature at around 8 a.m. on the administration day of each period.
Sponsors & Collaborators
-
Boryung Pharmaceutical Co., Ltd
lead INDUSTRY
Principal Investigators
-
Chang-Min Seong · Bestian Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-10-27
- Primary Completion
- 2021-12-18
- Completion
- 2021-12-18
Countries
- South Korea
Study Locations
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